Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01318135
• Collaborator: (none)
• Enrollment: 576
• Arms: 4
• Duration (Months): 14.9

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Alogliptin and glimepiride; Drug: Alogliptin and glimepiride; Drug: Alogliptin and metformin; Drug: Alogliptin and metformin	Phase 2/Phase 3

Detailed Description

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

Study Design

• Study Type: Interventional
• Actual Enrollment: 576 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Drug: Alogliptin and glimepiride; Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.; Other Names: SYR-322 Amaryl
Active Comparator: Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Drug: Alogliptin and glimepiride; Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.; Other Names: SYR-322 Amaryl
Active Comparator: Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Drug: Alogliptin and metformin; Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.; Other Names: SYR-322 Glycoran
Active Comparator: Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Drug: Alogliptin and metformin; Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.; Other Names: SYR-322 Glycoran

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events. [52 Weeks.]

   Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.

Secondary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (Week 8). [Baseline and Week 8.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.

2. Change From Baseline in Glycosylated Hemoglobin (Week 12). [Baseline and Week 12.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.

3. Change From Baseline in Glycosylated Hemoglobin (Week 16). [Baseline and Week 16.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.

4. Change From Baseline in Glycosylated Hemoglobin (Week 20). [Baseline and Week 20.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.

5. Change From Baseline in Glycosylated Hemoglobin (Week 24). [Baseline and Week 24.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.

6. Change From Baseline in Glycosylated Hemoglobin (Week 28). [Baseline and Week 28.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.

7. Change From Baseline in Glycosylated Hemoglobin (Week 32). [Baseline and Week 32.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.

8. Change From Baseline in Glycosylated Hemoglobin (Week 36). [Baseline and Week 36.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.

9. Change From Baseline in Glycosylated Hemoglobin (Week 40). [Baseline and Week 40.]

   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.

10. Change From Baseline in Glycosylated Hemoglobin (Week 44). [Baseline and Week 44.]

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.

11. Change From Baseline in Glycosylated Hemoglobin (Week 48). [Baseline and Week 48.]

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.

12. Change From Baseline in Glycosylated Hemoglobin (Week 52). [Baseline and Week 52.]

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.

13. Change From Baseline in Glycosylated Hemoglobin (Final Visit). [Baseline and Final Visit (up to 52).]

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.

14. Change From Baseline in Fasting Blood Glucose (Week 8). [Baseline and Week 8.]

    The change between the value of fasting blood glucose collected at week 8 and baseline.

15. Change From Baseline in Fasting Blood Glucose (Week 12). [Baseline and Week 12.]

    The change between the value of fasting blood glucose collected at week 12 and baseline.

16. Change From Baseline in Fasting Blood Glucose (Week 16). [Baseline and Week 16.]

    The change between the value of fasting blood glucose collected at week 6 and baseline.

17. Change From Baseline in Fasting Blood Glucose (Week 20). [Baseline and Week 20.]

    The change between the value of fasting blood glucose collected at week 20 and baseline.

18. Change From Baseline in Fasting Blood Glucose (Week 24). [Baseline and Week 24.]

    The change between the value of fasting blood glucose collected at week 24 and baseline.

19. Change From Baseline in Fasting Blood Glucose (Week 28). [Baseline and Week 28.]

    The change between the value of fasting blood glucose collected at week 28 and baseline.

20. Change From Baseline in Fasting Blood Glucose (Week 32). [Baseline and Week 32.]

    The change between the value of fasting blood glucose collected at week 32 and baseline.

21. Change From Baseline in Fasting Blood Glucose (Week 36). [Baseline and Week 36.]

    The change between the value of fasting blood glucose collected at week 36 and baseline.

22. Change From Baseline in Fasting Blood Glucose (Week 40). [Baseline and Week 40.]

    The change between the value of fasting blood glucose collected at week 40 and baseline.

23. Change From Baseline in Fasting Blood Glucose (Week 44). [Baseline and Week 44.]

    The change between the value of fasting blood glucose collected at week 44 and baseline.

24. Change From Baseline in Fasting Blood Glucose (Week 48). [Baseline and Week 48.]

    The change between the value of fasting blood glucose collected at week 48 and baseline.

25. Change From Baseline in Fasting Blood Glucose (Week 52). [Baseline and Week 52.]

    The change between the value of fasting blood glucose collected at week 52 and baseline.

26. Change From Baseline in Fasting Blood Glucose (Final Visit). [Baseline and Final Visit (up to Week 52).]

    The change between the value of fasting blood glucose collected at final visit and baseline.

27. Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). [Baseline and Week 12.]

    The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

28. Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24). [Baseline and Week 24.]

    The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

29. Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). [Baseline and Week 52.]

    The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

30. Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). [Baseline and Final Visit (up to Week 52).]

    The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

1. Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.

2. Was capable of understanding and complying with protocol requirements.

3. Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

1. With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

2. With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

3. With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Professor, Diabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT01318135
• Other Study ID Numbers: SYR-322/OCT-005; JapicCTI-090902; U1111-1119-6196
• First Posted: Mar 18, 2011
• Last Update Posted: Aug 16, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Takeda: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Glimepiride; Alogliptin

Study Results

Participant Flow

Recruitment Details	Participants enrolled at 58 investigative sites in Japan from 06 January 2009 to 23 January 2010.
Pre-assignment Detail	Participants who had completed a core phase 2/3 glimepiride (SYR-322/CCT-005; NCT01318083) or metformin (SYR-322/CCT-006; NCT01318109) add-on study were enrolled in one of four, once daily (QD) or twice-daily (BID) treatment groups. Five participants completed OCT-005 study without receiving the study drug.

Arm/Group Title	CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group	CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group	Glimepiride Monotherapy Group* → 12.5 mg Combination Group	Glimepiride Monotherapy Group* → 25 mg Combination Group	CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group	CCT/006 - 25 mg Dose Group* → 25 mg Combination Group	Metformin Monotherapy Group* → 12.5 mg Combination Group	Metformin Monotherapy Group* → 25 mg Combination Group
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. *for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.	Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. *for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.	Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. *for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.	Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. *for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. *for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. *for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. *for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. *for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
Period Title: Enrolled - Long-Term Extension Study
STARTED	99	102	46	49	91	90	50	49
COMPLETED	97	102	46	49	91	90	50	49
NOT COMPLETED	2	0	0	0	0	0	0	0
Period Title: Enrolled - Long-Term Extension Study
STARTED	97	102	46	49	90	87	50	49
COMPLETED	80	89	38	42	81	83	49	46
NOT COMPLETED	17	13	8	7	9	4	1	3

Baseline Characteristics

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Total
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Total of all reporting groups
Overall Participants	150	152	142	145	589
Age, Customized (participants) [Number]
≤ 64 years	93 (9.50) 62%	105 (8.92) 69.1%	142 (8.12) 100%	145 (8.41) 100%	485 82.3%
≥ 65 years	57 38%	47 30.9%	0 0%	0 0%	104 17.7%
Sex: Female, Male (Count of Participants)
Female	53 35.3%	52 34.2%	46 32.4%	44 30.3%	195 33.1%
Male	97 64.7%	100 65.8%	96 67.6%	101 69.7%	394 66.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events.
Description	Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Time Frame	52 Weeks.

Outcome Measure Data

Analysis Population Description

Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	150	152	142	145
Serious Adverse Event	16 10.7%	3 2%	7 4.9%	5 3.4%
Other Adverse Event (≥3% Frequency Threshold)	116 77.3%	134 88.2%	108 76.1%	113 77.9%

2. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 8).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 8.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	147	150	141	143
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.53 (0.506)	-0.65 (0.515)	-0.53 (0.486)	-0.59 (0.394)

3. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 12).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 12.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	145	148	140	142
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.63 (0.626)	-0.72 (0.589)	-0.61 (0.576)	-0.71 (0.489)

4. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 16).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 16.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	141	147	138	135
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.66 (0.685)	-0.76 (0.660)	-0.69 (0.614)	-0.78 (0.495)

5. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 20).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 20.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	139	146	136	134
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.63 (0.754)	-0.70 (0.689)	-0.67 (0.648)	-0.78 (0.553)

6. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 24).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 24.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	137	145	135	134
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.59 (0.823)	-0.70 (0.740)	-0.68 (0.668)	-0.78 (0.623)

7. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 28).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 28.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	132	144	135	132
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.62 (0.841)	-0.76 (0.721)	-0.70 (0.659)	-0.84 (0.596)

8. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 32).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 32.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	132	140	135	129
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.63 (0.868)	-0.77 (0.736)	-0.67 (0.644)	-0.81 (0.634)

9. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 36).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 36.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	128	137	134	129
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.64 (0.881)	-0.77 (0.745)	-0.67 (0.659)	-0.79 (0.653)

10. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 40).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 40.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	124	135	132	129
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.66 (0.799)	-0.74 (0.779)	-0.63 (0.676)	-0.74 (0.698)

11. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 44).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 44.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	84	90	81	83
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.48 (0.726)	-0.71 (0.666)	-0.47 (0.787)	-0.70 (0.688)

12. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 48).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 48.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	82	90	81	83
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.40 (0.706)	-0.61 (0.660)	-0.36 (0.762)	-0.62 (0.707)

13. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Week 52).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Week 52.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	80	89	81	83
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.33 (0.652)	-0.53 (0.643)	-0.29 (0.744)	-0.53 (0.790)

14. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Description	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.
Time Frame	Baseline and Final Visit (up to 52).

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	149	152	142	145
Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]	-0.42 (0.838)	-0.58 (0.791)	-0.44 (0.720)	-0.58 (0.781)

15. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 8).
Description	The change between the value of fasting blood glucose collected at week 8 and baseline.
Time Frame	Baseline and Week 8.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	147	150	141	143
Mean (Standard Deviation) [mg/dL]	-20.7 (26.50)	-19.6 (30.53)	-22.0 (22.76)	-23.4 (26.75)

16. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 12).
Description	The change between the value of fasting blood glucose collected at week 12 and baseline.
Time Frame	Baseline and Week 12.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	145	148	140	142
Mean (Standard Deviation) [mg/dL]	-22.0 (32.19)	-18.1 (29.05)	-22.9 (24.04)	-24.2 (27.30)

17. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 16).
Description	The change between the value of fasting blood glucose collected at week 6 and baseline.
Time Frame	Baseline and Week 16.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	141	147	138	135
Mean (Standard Deviation) [mg/dL]	-22.3 (34.37)	-17.8 (32.22)	-21.8 (26.86)	-26.1 (26.93)

18. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 20).
Description	The change between the value of fasting blood glucose collected at week 20 and baseline.
Time Frame	Baseline and Week 20.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	139	146	136	134
Mean (Standard Deviation) [mg/dL]	-22.4 (31.75)	-22.3 (30.93)	-23.4 (27.88)	-26.1 (26.19)

19. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 24).
Description	The change between the value of fasting blood glucose collected at week 24 and baseline.
Time Frame	Baseline and Week 24.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	137	145	135	133
Mean (Standard Deviation) [mg/dL]	-24.0 (31.69)	-25.0 (32.68)	-25.6 (24.22)	-26.3 (28.09)

20. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 28).
Description	The change between the value of fasting blood glucose collected at week 28 and baseline.
Time Frame	Baseline and Week 28.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	132	144	135	131
Mean (Standard Deviation) [mg/dL]	-19.9 (36.87)	-25.9 (33.67)	-25.8 (26.16)	-28.2 (29.49)

21. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 32).
Description	The change between the value of fasting blood glucose collected at week 32 and baseline.
Time Frame	Baseline and Week 32.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	132	139	135	129
Mean (Standard Deviation) [mg/dL]	-22.4 (37.47)	-26.1 (30.69)	-23.2 (25.71)	-28.2 (29.31)

22. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 36).
Description	The change between the value of fasting blood glucose collected at week 36 and baseline.
Time Frame	Baseline and Week 36.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	128	136	134	129
Mean (Standard Deviation) [mg/dL]	-25.5 (34.16)	-26.7 (33.12)	-23.4 (24.00)	-26.0 (31.26)

23. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 40).
Description	The change between the value of fasting blood glucose collected at week 40 and baseline.
Time Frame	Baseline and Week 40.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	124	135	132	129
Mean (Standard Deviation) [mg/dL]	-21.3 (33.44)	-22.7 (30.19)	-19.8 (24.81)	-23.2 (31.13)

24. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 44).
Description	The change between the value of fasting blood glucose collected at week 44 and baseline.
Time Frame	Baseline and Week 44.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	83	90	81	83
Mean (Standard Deviation) [mg/dL]	-15.4 (31.69)	-21.9 (29.33)	-16.3 (26.22)	-24.0 (31.49)

25. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 48).
Description	The change between the value of fasting blood glucose collected at week 48 and baseline.
Time Frame	Baseline and Week 48.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	82	90	81	83
Mean (Standard Deviation) [mg/dL]	-13.6 (28.29)	-16.6 (30.68)	-14.3 (24.22)	-23.3 (29.73)

26. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Week 52).
Description	The change between the value of fasting blood glucose collected at week 52 and baseline.
Time Frame	Baseline and Week 52.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	80	89	81	83
Mean (Standard Deviation) [mg/dL]	-13.3 (31.74)	-11.9 (30.11)	-14.0 (26.92)	-16.1 (29.60)

27. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose (Final Visit).
Description	The change between the value of fasting blood glucose collected at final visit and baseline.
Time Frame	Baseline and Final Visit (up to Week 52).

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	149	152	141	145
Mean (Standard Deviation) [mg/dL]	-16.0 (33.73)	-13.0 (34.68)	-16.4 (25.81)	-17.7 (29.54)

28. Secondary Outcome

Title	Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Description	The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame	Baseline and Week 12.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	146	149	141	143
Mean (Standard Deviation) [mg/dL]	80.2 (43.24)	80.1 (47.77)	61.6 (38.72)	64.0 (34.39)

29. Secondary Outcome

Title	Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
Description	The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame	Baseline and Week 24.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	97	101	85	84
Mean (Standard Deviation) [mg/dL]	87.4 (38.74)	77.9 (42.68)	60.7 (34.96)	62.4 (32.23)

30. Secondary Outcome

Title	Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
Description	The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame	Baseline and Week 52.

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	120	135	130	129
Mean (Standard Deviation) [mg/dL]	83.8 (46.24)	83.2 (43.61)	62.5 (42.91)	62.7 (32.81)

31. Secondary Outcome

Title	Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
Description	The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame	Baseline and Final Visit (up to Week 52).

Outcome Measure Data

Analysis Population Description

Values are from the Full Analysis Set.

Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Measure Participants	146	149	141	143
Mean (Standard Deviation) [mg/dL]	84.8 (45.47)	84.9 (44.35)	63.5 (43.06)	63.7 (32.32)

Adverse Events

Time Frame	Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
Adverse Event Reporting Description	The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
Arm/Group Title	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID		Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID		Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID		Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Arm/Group Description	Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.		Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.		Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.		Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
All Cause Mortality
	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID		Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID		Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID		Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID		Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID		Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID		Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/150 (10.7%)		3/152 (2%)		7/142 (4.9%)		5/145 (3.4%)
Cardiac disorders
Acute myocardial infarction	1/150 (0.7%)		0/152 (0%)		2/142 (1.4%)		0/145 (0%)
Angina pectoris	1/150 (0.7%)		1/152 (0.7%)		0/142 (0%)		0/145 (0%)
Cardiac failure	0/150 (0%)		0/152 (0%)		0/142 (0%)		1/145 (0.7%)
Ear and labyrinth disorders
Vertigo	0/150 (0%)		1/152 (0.7%)		0/142 (0%)		0/145 (0%)
Gastrointestinal disorders
Gastritis	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Mallory-Weiss syndrome	0/150 (0%)		0/152 (0%)		0/142 (0%)		1/145 (0.7%)
General disorders
Sudden death	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Infections and infestations
Cellulitis	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Enteritis infectious	0/150 (0%)		0/152 (0%)		1/142 (0.7%)		0/145 (0%)
Gas gangrene	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Pneumonia legionella	0/150 (0%)		0/152 (0%)		1/142 (0.7%)		0/145 (0%)
Injury, poisoning and procedural complications
Fall	1/150 (0.7%)		0/152 (0%)		1/142 (0.7%)		0/145 (0%)
Road traffic accident	2/150 (1.3%)		1/152 (0.7%)		1/142 (0.7%)		0/145 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/150 (0.7%)		0/0 (NaN)		0/142 (0%)		1/145 (0.7%)
Gastric cancer	2/150 (1.3%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Lung neoplasm malignant	1/150 (0.7%)		0/0 (NaN)		0/142 (0%)		1/145 (0.7%)
Malignant neoplasm of renal pelvis	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Pancreatic carcinoma	0/150 (0%)		0/1 (0%)		1/142 (0.7%)		0/145 (0%)
Prostate cancer	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Nervous system disorders
Cerebral circulatory failure	0/150 (0%)		0/152 (0%)		0/142 (0%)		1/145 (0.7%)
Cerebral infarction	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Embolic stroke	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Sciatica	1/150 (0.7%)		0/152 (0%)		0/142 (0%)		0/145 (0%)
Other (Not Including Serious) Adverse Events
	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID		Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID		Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID		Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	116/150 (77.3%)		134/152 (88.2%)		108/142 (76.1%)		113/145 (77.9%)
Eye disorders
Cataract	6/150 (4%)		7/152 (4.6%)		0/142 (0%)		0/145 (0%)
Conjunctivitis allergic	0/150 (0%)		0/152 (0%)		1/142 (0.7%)		6/145 (4.1%)
Diabetic retinopathy	4/150 (2.7%)		8/152 (5.3%)		6/142 (4.2%)		10/145 (6.9%)
Gastrointestinal disorders
Constipation	7/150 (4.7%)		7/152 (4.6%)		7/142 (4.9%)		8/145 (5.5%)
Dental caries	6/150 (4%)		1/152 (0.7%)		1/142 (0.7%)		7/145 (4.8%)
Diarrhoea	5/150 (3.3%)		3/152 (2%)		6/142 (4.2%)		3/145 (2.1%)
Gastritis	4/150 (2.7%)		8/152 (5.3%)		0/142 (0%)		0/145 (0%)
General disorders
Chest pain	1/150 (0.7%)		5/152 (3.3%)		0/142 (0%)		0/145 (0%)
Hepatobiliary disorders
Hepatic steatosis	0/150 (0%)		0/152 (0%)		2/142 (1.4%)		5/145 (3.4%)
Infections and infestations
Bronchitis	0/150 (0%)		0/152 (0%)		1/142 (0.7%)		6/145 (4.1%)
Cystitis	5/150 (3.3%)		5/152 (3.3%)		5/142 (3.5%)		4/145 (2.8%)
Gastroenteritis	7/150 (4.7%)		4/152 (2.6%)		0/142 (0%)		0/145 (0%)
Nasopharyngitis	46/150 (30.7%)		57/152 (37.5%)		44/142 (31%)		53/145 (36.6%)
Injury, poisoning and procedural complications
Fall	7/150 (4.7%)		12/152 (7.9%)		0/142 (0%)		0/145 (0%)
Investigations
Alanine aminotransferase increased	0/150 (0%)		0/152 (0%)		6/142 (4.2%)		2/145 (1.4%)
Blood creatine phosphokinase increased	2/150 (1.3%)		5/152 (3.3%)		0/142 (0%)		0/145 (0%)
White blood cell count increased	0/150 (0%)		0/152 (0%)		3/142 (2.1%)		5/145 (3.4%)
Metabolism and nutrition disorders
Hypoglycaemia	4/150 (2.7%)		8/152 (5.3%)		0/142 (0%)		0/145 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	6/150 (4%)		4/152 (2.6%)		2/142 (1.4%)		6/145 (4.1%)
Back pain	8/150 (5.3%)		11/152 (7.2%)		9/142 (6.3%)		6/145 (4.1%)
Musculoskeletal stiffness	0/150 (0%)		0/152 (0%)		1/142 (0.7%)		5/145 (3.4%)
Osteoarthritis	6/150 (4%)		1/152 (0.7%)		0/142 (0%)		0/145 (0%)
Periarthritis	7/150 (4.7%)		4/152 (2.6%)		0/142 (0%)		0/145 (0%)
Nervous system disorders
Headache	0/150 (0%)		0/152 (0%)		9/142 (6.3%)		3/145 (2.1%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	10/150 (6.7%)		16/152 (10.5%)		6/142 (4.2%)		6/145 (4.1%)
Skin and subcutaneous tissue disorders
Eczema	0/150 (0%)		0/152 (0%)		7/142 (4.9%)		6/145 (4.1%)
Urticaria	2/150 (1.3%)		5/152 (3.3%)		0/142 (0%)		0/145 (0%)
Vascular disorders
Hypertension	0/150 (0%)		0/152 (0%)		7/142 (4.9%)		4/145 (2.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.