Study of Multiple Doses of Saxagliptin (BMS-477118)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00950599
• Collaborator: (none)
• Enrollment: 423
• Arms: 7
• Duration (Months): 12

Study Details

Study Description

Brief Summary

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Saxagliptin; Drug: Saxagliptin; Drug: Saxagliptin; Drug: Saxagliptin; Drug: Saxagliptin; Drug: Saxagliptin; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 423 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: May 1, 2004
• Actual Study Completion Date: May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Saxagliptin (2.5 mg)	Drug: Saxagliptin; Tablets, Oral, 2.5 mg, once daily, 12 weeks; Other Names: BMS-477118
Experimental: Saxagliptin (5 mg)	Drug: Saxagliptin; Tablets, Oral, 5 mg, once daily, 12 weeks; Other Names: BMS-477118
Experimental: Saxagliptin (10 mg)	Drug: Saxagliptin; Tablets, Oral, 10 mg, once daily, 12 weeks; Other Names: BMS-477118
Experimental: Saxagliptin (20 mg)	Drug: Saxagliptin; Tablets, Oral, 20 mg, once daily, 12 weeks; Other Names: BMS-477118
Experimental: Saxagliptin (40 mg)	Drug: Saxagliptin; Tablets, Oral, 40 mg, once daily, 12 weeks; Other Names: BMS-477118
Experimental: Saxagliptin (100 mg)	Drug: Saxagliptin; Tablets, Oral, 100 mg, once daily, 6 weeks; Other Names: BMS-477118
Placebo Comparator: Placebo	Drug: Placebo; Tablets, Oral, 0 mg, once daily, 6 and 12 weeks

Outcome Measures

Primary Outcome Measures

1. Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

   Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.

2. Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

   Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

Secondary Outcome Measures

1. Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

   Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

2. Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

   Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

3. Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

   Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

4. Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

   Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

5. Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

   Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

6. Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

   Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

7. Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

   Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

8. Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

   Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

9. Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

   Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

10. Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.

11. Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.

12. Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.

13. Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.

14. Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.

15. Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.

16. Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

17. Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

18. Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

19. Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

20. Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

21. Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

22. Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

23. Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

24. Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

25. Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

26. Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

27. Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

28. Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

29. Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

30. Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

31. Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

32. Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

33. Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

34. Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

35. Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

36. Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

37. Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

38. Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

39. Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

40. Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

41. Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

42. Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

43. Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

44. Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

45. Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

46. Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

47. Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

48. Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

49. Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort

50. Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

51. Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

52. Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

53. Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.

54. Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

55. Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.

56. Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

57. Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.

58. Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.

59. Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.

60. Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.

61. Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.

62. Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. [Baseline, Week 6]

    Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.

63. Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.

64. Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 6]

    Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).

65. Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort [Baseline, Week 12]

    Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).

66. Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 14]

    Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.

67. Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 10, Week 16]

    Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.

68. Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 8, Week 14]

    Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.

69. Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 10, Week 16]

    Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.

70. Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 8, Week 14]

    Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.

71. Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts [Baseline, Week 10, Week 16]

    Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.

72. Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort [Baseline, Week 6]

    Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.

73. Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. [Baseline, Week 6]

    Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.

74. Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort [Baseline, Week 6]

    Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.

75. Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort [Week 6]

    Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.

76. Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)

77. Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort [Baseline, Week 6]

    Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)

78. Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control [Week 4, Week 6]

    Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)

79. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort [up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations]

    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

80. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort [up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations]

    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

81. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort [From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations]

    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

82. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort [From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations]

    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetes who are drug-naive

• Screening HbA1c ≥ 6.8% and ≤ 9.7%

• Screening fasting or random C-peptide > 0.5 ng/mL

• < 35 years old must be negative for anti-GAD antibodies

• Body Mass Index < 35 kg/m2

Exclusion Criteria:

• Symptoms of poorly controlled diabetes

• History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening

• Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis

• Significant cardiovascular history

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

• Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00950599
• Other Study ID Numbers: CV181-008
• First Posted: Aug 3, 2009
• Last Update Posted: Apr 3, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Saxagliptin

Study Results

Participant Flow

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)	Saxa 0-40 mg Cohort (Follow-up Period)	Saxa 0 & 100 mg Cohort (Follow-up Period)
Arm/Group Description	The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks	The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.	The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.	The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.	The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.	The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.	The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.	The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.	The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.	The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
Period Title: Double-Blind Treatment Period
STARTED	55	47	63	54	52	67	44	41	0	0
COMPLETED	48	37	54	43	45	55	44	35	0	0
NOT COMPLETED	7	10	9	11	7	12	0	6	0	0
Period Title: Double-Blind Treatment Period
STARTED	0	0	0	0	0	0	0	0	309	80
COMPLETED	0	0	0	0	0	0	0	0	296	78
NOT COMPLETED	0	0	0	0	0	0	0	0	13	2

Baseline Characteristics

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	55	47	63	54	52	67	44	41	423
Age, Customized (participants) [Number]
<65 years	50 90.9%	39 83%	54 85.7%	50 92.6%	41 78.8%	55 82.1%	38 86.4%	35 85.4%	362 85.6%
>= 65 years	5 9.1%	8 17%	9 14.3%	4 7.4%	11 21.2%	12 17.9%	6 13.6%	6 14.6%	61 14.4%
Sex: Female, Male (Count of Participants)
Female	33 60%	22 46.8%	23 36.5%	16 29.6%	22 42.3%	25 37.3%	17 38.6%	18 43.9%	176 41.6%
Male	22 40%	25 53.2%	40 63.5%	38 70.4%	30 57.7%	42 62.7%	27 61.4%	23 56.1%	247 58.4%

Outcome Measures

1. Primary Outcome

Title	Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Description	Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	51	42	60	51	50	62
Mean (Standard Deviation) [percentage of glycosylated hemoglobins]	-0.67 (0.80)	-0.95 (0.97)	-0.81 (0.91)	-0.74 (0.93)	-0.78 (1.04)	-0.29 (0.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saxagliptin 2.5 mg (0-40 mg Cohort), Saxagliptin 5 mg (0-40 mg Cohort), Saxagliptin 10 mg (0-40 mg Cohort), Saxagliptin 20 mg (0-40 mg Cohort), Saxagliptin 40 mg (0-40 mg Cohort), Placebo (0-40 mg Cohort)
	Comments	A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9888
	Comments	A significance level of alpha = 0.05 was used for the trend test.
	Method	Kruskal-Wallis
	Comments	ANCOVA Model: post-pre=pre treatment.

2. Primary Outcome

Title	Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	51	42	60	51	50	62
Mean (Standard Error) [percentage of glycosylated hemoglobins]	-0.72 (0.12)	-0.90 (0.14)	-0.81 (0.11)	-0.74 (0.12)	-0.80 (0.12)	-0.27 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saxagliptin 2.5 mg (0-40 mg Cohort), Saxagliptin 5 mg (0-40 mg Cohort), Saxagliptin 10 mg (0-40 mg Cohort), Saxagliptin 20 mg (0-40 mg Cohort), Saxagliptin 40 mg (0-40 mg Cohort), Placebo (0-40 mg Cohort)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9888
	Comments	Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.
	Method	ANCOVA
	Comments	ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.

3. Secondary Outcome

Title	Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	40	54	51	46	57	43	35
Mean (Standard Error) [percentage of glycosylated hemoglobins]	-0.71 (0.09)	-0.72 (0.10)	-0.67 (0.09)	-0.68 (0.09)	-0.82 (0.09)	-0.33 (0.08)	-1.09 (0.09)	-0.36 (0.09)

4. Secondary Outcome

Title	Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	50	46	61	53	50	63	43	37
Mean (Standard Error) [mg/dL]	-10.71 (3.68)	-18.63 (3.82)	-16.10 (3.32)	-14.66 (3.57)	-18.34 (3.67)	-6.20 (3.26)	-26.33 (3.53)	-3.29 (3.81)

5. Secondary Outcome

Title	Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	50	46	61	53	50	63
Mean (Standard Error) [mg/dL]	-10.85 (4.61)	-21.68 (4.80)	-15.91 (4.16)	-13.61 (4.48)	-16.36 (4.60)	2.81 (4.10)

6. Secondary Outcome

Title	Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	53	44	61	54	49	62	44	36
Mean (Standard Error) [umol/L]	-21.02 (3.91)	-21.87 (4.29)	-24.72 (3.65)	-23.96 (3.88)	-26.03 (4.07)	-9.26 (3.62)	-28.03 (3.74)	-0.16 (4.13)

7. Secondary Outcome

Title	Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	54	44	61	54	50	62
Mean (Standard Error) [umol/L]	-20.89 (4.64)	-25.23 (5.14)	-21.31 (4.36)	-22.30 (4.64)	-26.30 (4.82)	-8.57 (4.33)

8. Secondary Outcome

Title	Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0, 100 mg Cohort)	Placebo (0, 100 mg Cohort)
Arm/Group Description
Measure Participants	45	42	54	48	44	54	39	36
Mean (Standard Error) [uU/mL]	1.88 (1.22)	1.05 (1.26)	-0.99 (1.11)	-0.17 (1.18)	0.38 (1.23)	0.08 (1.11)	-2.03 (1.09)	-0.61 (1.13)

9. Secondary Outcome

Title	Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	42	30	47	37	41	49
Mean (Standard Error) [uU/mL]	2.38 (1.63)	1.02 (1.93)	1.41 (1.54)	0.76 (1.74)	2.29 (1.65)	1.29 (1.51)

10. Secondary Outcome

Title	Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	42	54	48	44	54	39	36
Mean (Standard Error) [ng/mL]	-0.15 (0.12)	-0.19 (0.13)	-0.06 (0.11)	-0.02 (0.12)	-0.03 (0.13)	-0.08 (0.11)	-0.52 (0.12)	-0.13 (0.13)

11. Secondary Outcome

Title	Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	42	30	47	37	41	49
Mean (Standard Error) [ng/mL]	-0.04 (0.14)	-0.13 (0.16)	-0.09 (0.13)	0.01 (0.14)	-0.02 (0.14)	0.02 (0.13)

12. Secondary Outcome

Title	Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	37	55	45	44	59	37	32
Mean (Standard Error) [mg*min/dL]	-1226 (318)	-1503 (353)	-1312 (290)	-1246 (320)	-1626 (324)	-461 (280)	-2035 (263)	-664 (283)

13. Secondary Outcome

Title	Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	39	29	47	38	40	52
Mean (Standard Error) [mg*min/dL]	-1121 (320)	-1505 (369)	-1730 (289)	-1377 (322)	-1520 (314)	174 (275)

14. Secondary Outcome

Title	Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	44	37	52	46	42	57	35	32
Mean (Standard Error) [uU*min/mL]	234.2 (149.5)	293.2 (162.3)	120.0 (136.6)	165.4 (145.3)	28.8 (152.4)	164.6 (130.5)	-296.0 (160.4)	261.9 (167.7)

15. Secondary Outcome

Title	Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	39	26	46	39	38	51
Mean (Standard Error) [uU*min/mL]	61.2 (179.9)	283.4 (218.0)	114.2 (163.6)	336.8 (177.7)	195.6 (180.7)	30.3 (155.6)

16. Secondary Outcome

Title	Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	44	37	52	46	43	57	34	32
Mean (Standard Error) [ng*min/mL]	0.2 (9.4)	7.6 (10.3)	-5.5 (8.7)	5.4 (9.2)	0.2 (9.5)	-0.8 (8.3)	-19.7 (9.8)	0.8 (10.1)

17. Secondary Outcome

Title	Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	39	26	46	39	38	51
Mean (Standard Error) [ng*min/mL]	-8.1 (11.5)	4.8 (14.0)	-1.6 (10.5)	7.1 (11.4)	-3.4 (11.6)	-4.0 (10.0)

18. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	35	52	48	40	51	39	34
Mean (Standard Error) [mg/dL]	-15.24 (5.22)	-16.53 (5.75)	-16.78 (4.72)	-14.35 (4.92)	-26.03 (5.38)	-9.30 (4.76)	-25.99 (4.30)	-6.80 (4.61)

19. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	34	52	48	42	51	39	33
Mean (Standard Error) [mg/dL]	-23.45 (6.09)	-29.31 (6.80)	-25.32 (5.52)	-23.93 (5.74)	-30.60 (6.12)	-7.81 (5.57)	-36.33 (4.99)	-10.94 (5.42)

20. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	33	52	48	42	51	38	35
Mean (Standard Error) [mg/dL]	-28.45 (6.85)	-39.99 (7.80)	-27.51 (6.21)	-24.32 (6.48)	-34.44 (6.90)	-4.96 (6.29)	-44.58 (5.65)	-17.22 (5.88)

21. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	30	49	38	41	51
Mean (Standard Error) [mg/dL]	-14.89 (4.78)	-16.45 (5.58)	-19.57 (4.35)	-18.70 (4.94)	-20.75 (4.77)	0.77 (4.27)

22. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	30	48	38	42	51
Mean (Standard Error) [mg/dL]	-19.79 (5.35)	-24.04 (6.21)	-28.59 (4.92)	-23.56 (5.52)	-20.42 (5.25)	-2.08 (4.76)

23. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	30	49	38	41	50
Mean (Standard Error) [mg/dL]	-24.42 (6.73)	-35.30 (7.84)	-41.04 (6.14)	-27.54 (6.97)	-33.98 (6.71)	-1.41 (6.08)

24. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	38	54	49	45	58	37	33
Mean (Standard Error) [uU/mL]	5.36 (2.74)	2.22 (3.02)	2.47 (2.53)	3.11 (2.66)	-0.60 (2.77)	0.60 (2.44)	-1.72 (3.07)	1.63 (3.25)

25. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	47	37	53	48	47	58	38	33
Mean (Standard Error) [uU/mL]	5.20 (3.39)	8.51 (3.81)	2.04 (3.18)	1.10 (3.35)	-0.33 (3.40)	4.82 (3.04)	-4.44 (3.30)	7.69 (3.54)

26. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	37	53	48	44	58	37	34
Mean (Standard Error) [uU/mL]	2.35 (4.06)	4.45 (4.49)	0.25 (3.73)	4.75 (3.93)	-0.13 (4.11)	3.33 (3.59)	-8.17 (4.37)	1.83 (4.56)

27. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	48	39	41	54
Mean (Standard Error) [uU/mL]	2.93 (3.67)	5.79 (4.49)	2.87 (3.37)	6.81 (3.74)	-1.48 (3.65)	4.70 (3.17)

28. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	47	39	42	54
Mean (Standard Error) [uU/mL]	0.98 (4.09)	10.71 (5.01)	2.48 (3.79)	5.90 (4.16)	6.14 (4.04)	1.19 (3.54)

29. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	48	39	39	53
Mean (Standard Error) [uU/mL]	2.62 (4.36)	4.61 (5.31)	0.38 (3.95)	4.99 (4.39)	2.42 (4.40)	-2.22 (3.80)

30. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	38	54	49	45	58	37	33
Mean (Standard Error) [ng/mL]	0.03 (0.17)	-0.09 (0.19)	-0.12 (0.16)	0.17 (0.17)	-0.14 (0.17)	-0.13 (0.15)	-0.27 (0.17)	0.01 (0.18)

31. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	47	37	53	48	47	58	37	33
Mean (Standard Error) [ng/mL]	0.13 (0.20)	0.16 (0.23)	-0.01 (0.19)	-0.06 (0.20)	-0.02 (0.21)	0.03 (0.18)	-0.35 (0.21)	0.05 (0.22)

32. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	37	53	48	45	58	37	34
Mean (Standard Error) [ng/mL]	-0.06 (0.22)	0.36 (0.25)	-0.16 (0.21)	0.20 (0.22)	0.19 (0.22)	0.24 (0.20)	-0.33 (0.25)	-0.10 (0.26)

33. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	48	39	41	54
Mean (Standard Error) [ng/mL]	-0.02 (0.23)	0.11 (0.28)	-0.12 (0.21)	-0.02 (0.23)	-0.27 (0.23)	0.07 (0.20)

34. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	47	39	42	54
Mean (Standard Error) [ng/mL]	-0.17 (0.23)	0.27 (0.29)	0.05 (0.22)	0.19 (0.24)	0.12 (0.23)	-0.14 (0.20)

35. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	48	39	39	53
Mean (Standard Error) [ng/mL]	-0.08 (0.26)	0.18 (0.31)	-0.02 (0.23)	0.22 (0.26)	0.01 (0.26)	0.22 (0.23)

36. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	48	39	56	45	44	59	38	33
Mean (Standard Error) [mg/dL]	1.42 (2.54)	-5.23 (2.82)	-1.15 (2.36)	3.48 (2.64)	-0.95 (2.65)	-2.37 (2.30)	-1.12 (2.35)	1.02 (2.52)

37. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	48	38	55	45	46	59	38	32
Mean (Standard Error) [mg/dL]	-7.39 (3.24)	-15.91 (3.64)	-6.92 (3.05)	-5.68 (3.34)	-6.89 (3.30)	-2.40 (2.92)	-12.76 (3.87)	-0.79 (4.22)

38. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	48	37	55	45	46	59	38	34
Mean (Standard Error) [mg/dL]	-10.08 (4.01)	-23.94 (4.57)	-12.94 (3.75)	-6.10 (4.14)	-11.88 (4.09)	-1.31 (3.63)	-20.69 (4.09)	-8.59 (4.32)

39. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	30	48	38	41	53
Mean (Standard Error) [mg/dL]	-1.20 (2.68)	0.02 (3.13)	1.63 (2.47)	3.14 (2.82)	-0.14 (2.68)	1.89 (2.36)

40. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	30	47	38	42	53
Mean (Standard Error) [mg/dL]	-5.99 (3.26)	-5.24 (3.82)	-5.69 (3.06)	-0.73 (3.40)	-0.12 (3.22)	0.79 (2.87)

41. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	30	48	38	41	52
Mean (Standard Error) [mg/dL]	-9.29 (4.26)	-16.51 (5.01)	-19.44 (3.94)	-3.95 (4.43)	-13.83 (4.27)	0.30 (3.79)

42. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	38	53	47	45	57	37	33
Mean (Standard Error) [uU/mL]	5.58 (2.53)	-1.04 (2.75)	2.85 (2.32)	1.18 (2.47)	0.11 (2.52)	-0.28 (2.24)	2.19 (2.62)	2.67 (2.78)

43. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	37	52	46	47	57	38	33
Mean (Standard Error) [uU/mL]	4.95 (3.25)	5.07 (3.61)	2.40 (3.05)	-0.89 (3.24)	0.13 (3.23)	3.23 (2.91)	0.22 (3.05)	9.87 (3.27)

44. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	37	52	46	44	57	37	34
Mean (Standard Error) [uU/mL]	4.03 (3.93)	1.84 (4.29)	0.75 (3.60)	2.28 (3.83)	-0.16 (3.93)	1.82 (3.47)	-3.61 (3.78)	4.19 (3.95)

45. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	47	39	41	52
Mean (Standard Error) [uU/mL]	2.33 (3.08)	5.26 (3.76)	1.98 (2.85)	3.56 (3.14)	-1.49 (3.05)	4.42 (2.71)

46. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	46	39	42	52
Mean (Standard Error) [uU/mL]	-0.23 (3.47)	10.17 (4.25)	1.43 (3.25)	3.35 (3.53)	5.36 (3.44)	-0.70 (3.06)

47. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	47	39	39	51
Mean (Standard Error) [uU/mL]	2.71 (3.97)	4.85 (4.82)	-0.83 (3.63)	2.02 (3.99)	1.44 (4.01)	-3.52 (3.51)

48. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	38	53	47	45	57	37	33
Mean (Standard Error) [ng/mL]	0.29 (0.14)	-0.08 (0.16)	0.10 (0.13)	0.08 (0.14)	0.01 (0.14)	0.01 (0.13)	0.01 (0.15)	0.17 (0.16)

49. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	37	52	46	47	57	37	33
Mean (Standard Error) [ng/mL]	0.35 (0.18)	0.11 (0.20)	0.23 (0.17)	-0.07 (0.18)	0.12 (0.18)	0.09 (0.16)	-0.00 (0.20)	0.31 (0.21)

50. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	37	52	46	45	57	37	34
Mean (Standard Error) [ng/mL]	0.27 (0.20)	0.35 (0.22)	0.17 (0.19)	0.12 (0.20)	0.36 (0.20)	0.17 (0.18)	0.04 (0.21)	0.20 (0.21)

51. Secondary Outcome

Title	Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	47	39	41	52
Mean (Standard Error) [ng/mL]	0.23 (0.16)	0.42 (0.20)	0.02 (0.15)	0.02 (0.17)	-0.04 (0.16)	0.21 (0.15)

52. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	46	39	42	52
Mean (Standard Error) [ng/mL]	0.05 (0.20)	0.58 (0.24)	0.16 (0.18)	0.28 (0.20)	0.32 (0.19)	-0.08 (0.17)

53. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	41	27	47	39	39	51
Mean (Standard Error) [ng/mL]	0.29 (0.22)	0.59 (0.27)	0.16 (0.20)	0.27 (0.22)	0.20 (0.22)	0.13 (0.20)

54. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	30	46	35	41	50	31	30
Mean (Standard Error) [pg/mL]	-11.84 (4.11)	-10.92 (4.93)	-11.26 (3.99)	-5.81 (4.56)	-9.04 (4.21)	-1.98 (3.82)	-14.97 (3.69)	1.17 (3.75)

55. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	40	22	37	30	35	43
Mean (Standard Error) [pg/mL]	-8.39 (4.12)	-6.06 (5.57)	-12.64 (4.30)	-17.21 (4.76)	-11.90 (4.41)	-3.64 (3.98)

56. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	37	35	48	40	39	44	39	32
Mean (Standard Error) [mEg/L]	0.01 (0.03)	-0.03 (0.03)	-0.07 (0.02)	-0.08 (0.03)	-0.05 (0.03)	-0.02 (0.02)	-0.17 (0.02)	-0.16 (0.02)

57. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	32	26	44	32	37	41
Mean (Standard Error) [mEg/L]	0.01 (0.03)	-0.00 (0.03)	-0.06 (0.03)	-0.05 (0.03)	-0.04 (0.03)	-0.00 (0.03)

58. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	29	44	35	40	48	31	28
Mean (Standard Error) [pg/mL]	-5.94 (3.64)	-5.75 (4.42)	-10.39 (3.60)	-3.94 (4.02)	-6.99 (3.76)	3.58 (3.45)	-8.54 (3.87)	0.52 (4.07)

59. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	39	21	36	30	35	42
Mean (Standard Error) [pg/mL]	-5.96 (3.29)	-4.46 (4.47)	-6.80 (3.42)	-10.36 (3.74)	-8.56 (3.47)	4.53 (3.17)

60. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	34	30	40	34	36	41	39	31
Mean (Standard Error) [mEq/mL]	-0.02 (0.02)	0.01 (0.02)	-0.02 (0.02)	0.00 (0.02)	0.02 (0.02)	-0.01 (0.02)	-0.07 (0.02)	-0.12 (0.03)

61. Secondary Outcome

Title	Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
Description	Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	32	21	40	28	32	38
Mean (Standard Error) [mEq/mL]	-0.01 (0.02)	-0.04 (0.03)	0.02 (0.02)	-0.01 (0.02)	0.03 (0.02)	-0.04 (0.02)

62. Secondary Outcome

Title	Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	34	20	41	27	31	40	31	23
Mean (Standard Deviation) [units on a scale]	0.38 (2.04)	-0.31 (2.41)	0.45 (1.88)	-0.22 (1.22)	0.04 (2.00)	0.22 (1.80)	-0.25 (4.52)	-0.63 (2.77)

63. Secondary Outcome

Title	Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Description	Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	28	16	35	26	26	39
Mean (Standard Deviation) [units on a scale]	0.50 (2.03)	-0.19 (1.77)	-0.13 (1.91)	-0.34 (1.21)	0.22 (1.54)	-0.05 (1.38)

64. Secondary Outcome

Title	Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
Description	Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	34	20	41	27	31	40	31	23
Mean (Standard Deviation) [units on a scale]	0.44 (1.06)	0.37 (0.76)	0.31 (0.77)	0.18 (0.81)	0.71 (3.71)	0.04 (0.72)	0.46 (1.17)	-0.05 (0.83)

65. Secondary Outcome

Title	Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Description	Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	28	16	35	26	26	39
Mean (Standard Deviation) [units on a scale]	0.15 (0.99)	0.84 (2.31)	0.35 (0.97)	-0.05 (0.50)	0.25 (0.58)	0.11 (0.44)

66. Secondary Outcome

Title	Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	44	36	52	45	42	57	35	31
Mean (Standard Deviation) [units on a scale]	-0.36 (1.36)	0.31 (1.27)	-0.04 (2.84)	0.31 (1.76)	-0.06 (2.49)	-0.25 (1.91)	0.86 (2.86)	0.35 (2.45)

67. Secondary Outcome

Title	Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
Description	Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	40	26	45	40	39	51
Mean (Standard Deviation) [units on a scale]	-0.48 (2.81)	0.34 (1.21)	0.27 (3.90)	0.78 (3.24)	0.17 (3.68)	-0.15 (1.66)

68. Secondary Outcome

Title	Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	47	39	55	47	46	59	41	32
Mean (Standard Deviation) [percentage of glycated hemoglobins]	-0.55 (0.93)	-0.84 (1.04)	-0.78 (0.98)	-0.66 (1.03)	-0.69 (1.04)	-0.25 (0.83)	-1.15 (0.76)	-0.45 (0.65)

69. Secondary Outcome

Title	Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 10, Week 16

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	47	40	56	42	45	56	41	32
Mean (Standard Deviation) [percentage of glycated hemoglobins]	-0.34 (0.98)	-0.72 (0.96)	-0.64 (0.99)	-0.57 (0.94)	-0.53 (0.97)	-0.24 (0.87)	-1.01 (0.70)	-0.43 (0.80)

70. Secondary Outcome

Title	Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 8, Week 14

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	46	39	55	47	47	56	43	32
Mean (Standard Deviation) [mg/dL]	-1.93 (36.86)	-14.03 (34.62)	-7.58 (29.35)	-11.17 (33.97)	-6.02 (38.40)	-0.75 (29.11)	-14.14 (26.14)	-3.47 (26.80)

71. Secondary Outcome

Title	Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 10, Week 16

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	45	40	54	44	44	55	39	32
Mean (Standard Deviation) [mg/dL]	-5.82 (31.60)	-11.55 (33.73)	-6.65 (46.36)	-9.05 (28.62)	-0.91 (33.94)	-2.04 (40.19)	-7.82 (23.88)	-5.97 (21.76)

72. Secondary Outcome

Title	Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 8, Week 14

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	47	40	56	48	47	58	44	32
Mean (Standard Deviation) [umol/L]	-12.40 (35.18)	-19.78 (33.80)	-12.77 (37.92)	-17.10 (39.36)	-12.81 (32.41)	-7.48 (34.15)	-21.86 (31.39)	-5.97 (23.67)

73. Secondary Outcome

Title	Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Description	Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 10, Week 16

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	47	41	55	45	44	56	40	32
Mean (Standard Deviation) [umol/L]	-8.60 (39.61)	-8.02 (37.54)	-11.02 (40.73)	-19.44 (37.39)	-10.14 (31.45)	-7.05 (35.13)	-15.25 (30.78)	-10.00 (24.26)

74. Secondary Outcome

Title	Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
Description	Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	35
<7% (n=8; n=12)	-0.61 (0.26)	-0.18 (0.27)
≥7% to <8% (n=20; n=8)	-1.01 (0.41)	-0.30 (0.15)
≥8% to <9% (n=9; n=11)	-1.14 (0.53)	-0.34 (0.95)
≥9% (n=6; n=4)	-2.10 (0.88)	-0.83 (0.31)

75. Secondary Outcome

Title	Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
Description	Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	43	37
< 140 mg/dL (n=17; n=17)	-11.12 (12.51)	1.29 (12.95)
140 - < 180 mg/dL (n=17; n=14)	-27.00 (19.47)	0.07 (26.78)
≥180 mg/dL (n=9; n=6)	-56.89 (25.21)	-19.50 (48.14)

76. Secondary Outcome

Title	Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
Description	Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	38	35
<140 mg/dL (n=1; n=3)	-18.00 (0.00)	11.33 (12.10)
≥140 to <200 mg/dL (n=17; n=12)	-24.29 (21.44)	-19.25 (25.30)
≥200 mg/dL (n=20; n=20)	-62.10 (34.83)	-21.35 (57.10)

77. Secondary Outcome

Title	Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
Description	Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	44	41
Number [Percentage of Participants]	72 130.9%	49 104.3%

78. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort
Description	Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	0	0

79. Secondary Outcome

Title	Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort
Description	Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	0	0

80. Secondary Outcome

Title	Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control
Description	Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)
Time Frame	Week 4, Week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	0	0	0	0	0	0	0	0

81. Secondary Outcome

Title	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame	up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations

Outcome Measure Data

Analysis Population Description

All participants randomized and treated during the double-blind period.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	55	47	63	54	52	67
At least one AE	80.0 145.5%	76.6 163%	77.8 123.5%	87.0 161.1%	75.0 144.2%	79.1 118.1%
At least one SAE	1.8 3.3%	0 0%	1.6 2.5%	1.9 3.5%	0 0%	1.5 2.2%
At least one related AE	14.5 26.4%	23.4 49.8%	22.2 35.2%	25.9 48%	23.1 44.4%	23.9 35.7%
Deaths	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Discontinuations due to AEs	0 0%	2.1 4.5%	1.6 2.5%	1.9 3.5%	3.8 7.3%	1.5 2.2%

82. Secondary Outcome

Title	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame	up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations

Outcome Measure Data

Analysis Population Description

All participants randomized and treated during the double-blind period.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 Cohort)
Arm/Group Description
Measure Participants	44	41
At least one AE	65.9 119.8%	58.5 124.5%
At least one SAE	0 0%	0 0%
At least one related AE	22.7 41.3%	12.2 26%
Deaths	0 0%	0 0%
Discontinuations due to AEs	0 0%	0 0%

83. Secondary Outcome

Title	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame	From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations

Outcome Measure Data

Analysis Population Description

All participants treated during the follow-up period.

Arm/Group Title	Saxagliptin 2.5 mg (0-40 mg Cohort)	Saxagliptin 5 mg (0-40 mg Cohort)	Saxagliptin 10 mg (0-40 mg Cohort)	Saxagliptin 20 mg (0-40 mg Cohort)	Saxagliptin 40 mg (0-40 mg Cohort)	Placebo (0-40 mg Cohort)
Arm/Group Description
Measure Participants	50	42	58	48	47	60
At least one AE	34.0 61.8%	42.9 91.3%	37.9 60.2%	37.5 69.4%	42.6 81.9%	26.7 39.9%
At least one SAE	0 0%	0 0%	0 0%	2.1 3.9%	0 0%	1.7 2.5%
At least one related AE	4.0 7.3%	7.1 15.1%	3.4 5.4%	12.5 23.1%	4.3 8.3%	6.7 10%
Deaths	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Discontinuations due to AEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

84. Secondary Outcome

Title	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame	From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations

Outcome Measure Data

Analysis Population Description

All participants treated during the follow-up period.

Arm/Group Title	Saxagliptin 100 mg (0 & 100 mg Cohort)	Placebo (0 & 100 mg Cohort)
Arm/Group Description
Measure Participants	44	36
At least one AE	31.8 57.8%	33.3 70.9%
At least one SAE	0 0%	0 0%
At least one related SAE	2.3 4.2%	0 0%
Deaths	0 0%	0 0%
Discontinuations due to AEs	0 0%	0 0%

Adverse Events

Arm/Group Title	Saxagliptin 10 mg (0-40 mg Cohort)		Saxagliptin 100 mg (0 & 100 mg Cohort)		Saxagliptin 2.5 mg (0-40 mg Cohort)		Saxagliptin 20 mg (0-40 mg Cohort)		Saxagliptin 40 mg (0-40 mg Cohort)		Saxagliptin 5 mg (0-40 mg Cohort)		Placebo (0 & 100 mg Cohort)		Placebo (0-40 mg Cohort)
Arm/Group Description	The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.		The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.		The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks		The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.		The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.		The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.		The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.		The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
All Cause Mortality
	Saxagliptin 10 mg (0-40 mg Cohort)		Saxagliptin 100 mg (0 & 100 mg Cohort)		Saxagliptin 2.5 mg (0-40 mg Cohort)		Saxagliptin 20 mg (0-40 mg Cohort)		Saxagliptin 40 mg (0-40 mg Cohort)		Saxagliptin 5 mg (0-40 mg Cohort)		Placebo (0 & 100 mg Cohort)		Placebo (0-40 mg Cohort)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Saxagliptin 10 mg (0-40 mg Cohort)		Saxagliptin 100 mg (0 & 100 mg Cohort)		Saxagliptin 2.5 mg (0-40 mg Cohort)		Saxagliptin 20 mg (0-40 mg Cohort)		Saxagliptin 40 mg (0-40 mg Cohort)		Saxagliptin 5 mg (0-40 mg Cohort)		Placebo (0 & 100 mg Cohort)		Placebo (0-40 mg Cohort)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/63 (1.6%)		0/44 (0%)		1/55 (1.8%)		2/54 (3.7%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		2/67 (3%)
Gastrointestinal disorders
Rectocele	0/63 (0%)		0/44 (0%)		0/55 (0%)		1/54 (1.9%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		0/67 (0%)
Umbilical Hernia	0/63 (0%)		0/44 (0%)		0/55 (0%)		0/54 (0%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		1/67 (1.5%)
Infections and infestations
Pneumonia	0/63 (0%)		0/44 (0%)		1/55 (1.8%)		0/54 (0%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		0/67 (0%)
Appendicitis	1/63 (1.6%)		0/44 (0%)		0/55 (0%)		0/54 (0%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		0/67 (0%)
Gastroenteritis	0/63 (0%)		0/44 (0%)		0/55 (0%)		1/54 (1.9%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		0/67 (0%)
Urinary Tract Infection	0/63 (0%)		0/44 (0%)		0/55 (0%)		0/54 (0%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		1/67 (1.5%)
Renal and urinary disorders
Cystocele	0/63 (0%)		0/44 (0%)		0/55 (0%)		1/54 (1.9%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	Saxagliptin 10 mg (0-40 mg Cohort)		Saxagliptin 100 mg (0 & 100 mg Cohort)		Saxagliptin 2.5 mg (0-40 mg Cohort)		Saxagliptin 20 mg (0-40 mg Cohort)		Saxagliptin 40 mg (0-40 mg Cohort)		Saxagliptin 5 mg (0-40 mg Cohort)		Placebo (0 & 100 mg Cohort)		Placebo (0-40 mg Cohort)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/63 (57.1%)		16/44 (36.4%)		35/55 (63.6%)		33/54 (61.1%)		27/52 (51.9%)		23/47 (48.9%)		17/41 (41.5%)		38/67 (56.7%)
Gastrointestinal disorders
Nausea	2/63 (3.2%)		0/44 (0%)		1/55 (1.8%)		2/54 (3.7%)		5/52 (9.6%)		2/47 (4.3%)		2/41 (4.9%)		5/67 (7.5%)
Diarrhoea	2/63 (3.2%)		2/44 (4.5%)		3/55 (5.5%)		0/54 (0%)		1/52 (1.9%)		3/47 (6.4%)		0/41 (0%)		4/67 (6%)
Dyspepsia	1/63 (1.6%)		0/44 (0%)		0/55 (0%)		4/54 (7.4%)		1/52 (1.9%)		1/47 (2.1%)		0/41 (0%)		0/67 (0%)
Constipation	3/63 (4.8%)		3/44 (6.8%)		3/55 (5.5%)		3/54 (5.6%)		3/52 (5.8%)		0/47 (0%)		2/41 (4.9%)		2/67 (3%)
General disorders
Fatigue	1/63 (1.6%)		3/44 (6.8%)		2/55 (3.6%)		2/54 (3.7%)		3/52 (5.8%)		0/47 (0%)		2/41 (4.9%)		0/67 (0%)
Oedema Peripheral	4/63 (6.3%)		2/44 (4.5%)		0/55 (0%)		1/54 (1.9%)		2/52 (3.8%)		1/47 (2.1%)		1/41 (2.4%)		8/67 (11.9%)
Infections and infestations
Influenza	2/63 (3.2%)		0/44 (0%)		3/55 (5.5%)		1/54 (1.9%)		2/52 (3.8%)		0/47 (0%)		1/41 (2.4%)		3/67 (4.5%)
Sinusitis	4/63 (6.3%)		2/44 (4.5%)		2/55 (3.6%)		1/54 (1.9%)		1/52 (1.9%)		2/47 (4.3%)		2/41 (4.9%)		4/67 (6%)
Bronchitis	2/63 (3.2%)		0/44 (0%)		1/55 (1.8%)		1/54 (1.9%)		1/52 (1.9%)		1/47 (2.1%)		0/41 (0%)		4/67 (6%)
Nasopharyngitis	5/63 (7.9%)		1/44 (2.3%)		0/55 (0%)		3/54 (5.6%)		6/52 (11.5%)		2/47 (4.3%)		1/41 (2.4%)		5/67 (7.5%)
Urinary Tract Infection	4/63 (6.3%)		4/44 (9.1%)		6/55 (10.9%)		5/54 (9.3%)		2/52 (3.8%)		2/47 (4.3%)		2/41 (4.9%)		5/67 (7.5%)
Upper Respiratory Tract Infection	6/63 (9.5%)		0/44 (0%)		6/55 (10.9%)		6/54 (11.1%)		0/52 (0%)		3/47 (6.4%)		0/41 (0%)		4/67 (6%)
Investigations
Blood Pressure Increased	0/63 (0%)		0/44 (0%)		0/55 (0%)		0/54 (0%)		0/52 (0%)		0/47 (0%)		0/41 (0%)		4/67 (6%)
Blood Creatine Phosphokinase Increased	0/63 (0%)		1/44 (2.3%)		1/55 (1.8%)		2/54 (3.7%)		2/52 (3.8%)		3/47 (6.4%)		0/41 (0%)		1/67 (1.5%)
Musculoskeletal and connective tissue disorders
Back Pain	1/63 (1.6%)		0/44 (0%)		3/55 (5.5%)		4/54 (7.4%)		1/52 (1.9%)		2/47 (4.3%)		0/41 (0%)		3/67 (4.5%)
Arthralgia	3/63 (4.8%)		1/44 (2.3%)		6/55 (10.9%)		5/54 (9.3%)		2/52 (3.8%)		3/47 (6.4%)		1/41 (2.4%)		2/67 (3%)
Pain in Extremity	2/63 (3.2%)		0/44 (0%)		3/55 (5.5%)		2/54 (3.7%)		3/52 (5.8%)		2/47 (4.3%)		1/41 (2.4%)		3/67 (4.5%)
Nervous system disorders
Headache	10/63 (15.9%)		5/44 (11.4%)		8/55 (14.5%)		6/54 (11.1%)		5/52 (9.6%)		4/47 (8.5%)		2/41 (4.9%)		6/67 (9%)
Respiratory, thoracic and mediastinal disorders
Cough	1/63 (1.6%)		2/44 (4.5%)		4/55 (7.3%)		3/54 (5.6%)		3/52 (5.8%)		3/47 (6.4%)		0/41 (0%)		3/67 (4.5%)
Nasal Congestion	3/63 (4.8%)		2/44 (4.5%)		1/55 (1.8%)		0/54 (0%)		1/52 (1.9%)		3/47 (6.4%)		1/41 (2.4%)		2/67 (3%)
Pharyngolaryngeal Pain	0/63 (0%)		1/44 (2.3%)		2/55 (3.6%)		1/54 (1.9%)		2/52 (3.8%)		3/47 (6.4%)		0/41 (0%)		4/67 (6%)
Skin and subcutaneous tissue disorders
Rash	1/63 (1.6%)		0/44 (0%)		3/55 (5.5%)		1/54 (1.9%)		2/52 (3.8%)		1/47 (2.1%)		0/41 (0%)		1/67 (1.5%)
Vascular disorders
Hot Flush	1/63 (1.6%)		0/44 (0%)		3/55 (5.5%)		0/54 (0%)		1/52 (1.9%)		0/47 (0%)		0/41 (0%)		1/67 (1.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.