Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01945242
• Collaborator: (none)
• Enrollment: 1,374
• Duration (Months): 39

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Melitus	Drug: Alogliptin

Detailed Description

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting.

Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Study Design

• Study Type: Observational
• Actual Enrollment: 1374 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Nesina Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Alogilptin 25mg, tablets, orally, once daily, up to 12 months	Drug: Alogliptin; Alogliptin tablets; Other Names: Nesina; SYR-322

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting One or More Adverse Drug Reactions [Baseline up to 12 months]

   Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.

2. Number of Participants Reporting One or More Serious Adverse Drug Reactions [Baseline up to 12 months]

   Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.

Secondary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)]

   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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.

2. Percentage of Participants of Achieving Objective Glycemic Control [Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)]

   The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.

3. Change From Baseline in Fasting Blood Glucose [Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)]

   The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.

4. Change From Baseline in Fasting Insulin [Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)]

   The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy

Exclusion Criteria:

• Patients contraindicated for Nesina

1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)

2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)

3. Patients with a history of hypersensitivity to any ingredient of Nesina

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Takeda

Investigators

• Study Chair: Postmarketing Group Manager, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT01945242
• Other Study ID Numbers: 121-012; JapicCTI-132265; JapicCTI-R150770
• First Posted: Sep 18, 2013
• Last Update Posted: Sep 27, 2016
• Last Verified: Sep 1, 2016

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

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 252 investigative site in Japan from 25 March 2011 to 30 June 2014.
Pre-assignment Detail	Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment receiving thiazolidinediones were enrolled in 1 of 2 treatment groups as follows: alogliptin + thiazolidinediones; alogliptin + other.

Arm/Group Title	Alogliptin + Thiazolidinedione	Alogliptin + Other
Arm/Group Description	Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
Period Title: Overall Study
STARTED	1251	123
COMPLETED	1248	120
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Alogliptin + Thiazolidinedione	Alogliptin + Other	Total
Arm/Group Description	Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.	Total of all reporting groups
Overall Participants	1248	120	1368
Age, Customized (participants) [Number]
Less than (<) 20 years	1 0.1%	0 0%	1 0.1%
20-29 years	5 0.4%	0 0%	5 0.4%
30-39 years	29 2.3%	4 3.3%	33 2.4%
40-49 years	120 9.6%	12 10%	132 9.6%
50-59 years	214 17.1%	22 18.3%	236 17.3%
60-69 years	412 33%	35 29.2%	447 32.7%
70-79 years	337 27%	39 32.5%	376 27.5%
Greater than equal to (>=) 80 years	130 10.4%	8 6.7%	138 10.1%
Sex: Female, Male (Count of Participants)
Female	462 37%	41 34.2%	503 36.8%
Male	786 63%	79 65.8%	865 63.2%
Body Mass Index (participants) [Number]
<18.5 kilogram/square meter (kg/m^2)	16 1.3%	0 0%	16 1.2%
>=18.5 to <25 kg/m^2	318 25.5%	26 21.7%	344 25.1%
>=25 to <30 kg/m^2	353 28.3%	31 25.8%	384 28.1%
>=30 kg/m^2	134 10.7%	16 13.3%	150 11%
Unknown	427 34.2%	47 39.2%	474 34.6%
Waist Circumference (participants) [Number]
<85 centimeter (cm) (Male)	60 4.8%	7 5.8%	67 4.9%
>=85 cm (Male)	184 14.7%	17 14.2%	201 14.7%
Unknown (Male)	542 43.4%	55 45.8%	597 43.6%
<90 cm (Female)	92 7.4%	4 3.3%	96 7%
>=90 cm (Female)	49 3.9%	4 3.3%	53 3.9%
Unknown (Female)	321 25.7%	33 27.5%	354 25.9%
Pregnancy Status (participants) [Number]
Not pregnant	462 37%	41 34.2%	503 36.8%
Pregnant	0 0%	0 0%	0 0%
Healthcare category (participants) [Number]
Outpatient	1209 96.9%	120 100%	1329 97.1%
Inpatient	11 0.9%	0 0%	11 0.8%
Outpatient and Inpatient	28 2.2%	0 0%	28 2%
Health-related Complications (participants) [Number]
Had Complications	1064 85.3%	96 80%	1160 84.8%
Had No Complications	184 14.7%	24 20%	208 15.2%
Diabetic complications (participants) [Number]
Had Diabetic Complications	203 16.3%	15 12.5%	218 15.9%
Had No Diabetic Complications	1045 83.7%	105 87.5%	1150 84.1%
Breakdown of diabetic complications (participants) [Number]
Diabetic nephropathy	128 10.3%	5 4.2%	133 9.7%
Diabetic retinopathy	65 5.2%	9 7.5%	74 5.4%
Diabetic neuropathy	71 5.7%	6 5%	77 5.6%
Complications of Hypertension (participants) [Number]
Had Hypertension Complications	760 60.9%	69 57.5%	829 60.6%
Had No Hypertension Complications	488 39.1%	51 42.5%	539 39.4%
Complications of Dyslipidemia (participants) [Number]
Had Dyslipidemia Complications	766 61.4%	63 52.5%	829 60.6%
Had No Dyslipidemia Complications	482 38.6%	57 47.5%	539 39.4%
Complications of Hyperuricemia (participants) [Number]
Had Hyperuricemia Complications	106 8.5%	10 8.3%	116 8.5%
Had No Hyperuricemia Complications	1142 91.5%	110 91.7%	1252 91.5%
Complications of Liver Damage (participants) [Number]
Had Liver Damage Complications	200 16%	18 15%	218 15.9%
Had No Liver Damage Complications	1048 84%	102 85%	1150 84.1%
Breakdown of Complications of Liver Damage (participants) [Number]
Hepatic steatosis	158 12.7%	14 11.7%	172 12.6%
Hepatitis alcoholic	18 1.4%	1 0.8%	19 1.4%
Chronic hepatitis	17 1.4%	2 1.7%	19 1.4%
Hepatic cirrhosis	5 0.4%	0 0%	5 0.4%
Other	8 0.6%	2 1.7%	10 0.7%
Degree of Hepatic Dysfunction (participants) [Number]
Normal	769 61.6%	74 61.7%	843 61.6%
Grade 1	89 7.1%	10 8.3%	99 7.2%
Grade 2	11 0.9%	0 0%	11 0.8%
Grade 3	0 0%	0 0%	0 0%
Unknown	379 30.4%	36 30%	415 30.3%
Complications of Renal Damage (participants) [Number]
Had Renal Damage Complications	138 11.1%	5 4.2%	143 10.5%
Had No Renal Damage Complications	1110 88.9%	115 95.8%	1225 89.5%
Breakdown of Complications of Renal Damage (participants) [Number]
Nephrotic syndrome	1 0.1%	0 0%	1 0.1%
Glomerulonephritis	3 0.2%	0 0%	3 0.2%
Renal failure chronic	8 0.6%	0 0%	8 0.6%
Other	126 10.1%	5 4.2%	131 9.6%
Degree of Renal Dysfunction (participants) [Number]
Normal	198 15.9%	26 21.7%	224 16.4%
Mild	488 39.1%	46 38.3%	534 39%
Moderate	174 13.9%	15 12.5%	189 13.8%
Severe	10 0.8%	0 0%	10 0.7%
Unknown	378 30.3%	33 27.5%	411 30%
Complications of Heart Disease (participants) [Number]
Had Heart Disease Complications	142 11.4%	9 7.5%	151 11%
Had No Heart Disease Complications	1106 88.6%	111 92.5%	1217 89%
Breakdown of Complications of Heart Disease (participants) [Number]
Cardiac failure	16 1.3%	2 1.7%	18 1.3%
Myocardial infarction	27 2.2%	3 2.5%	30 2.2%
Angina pectoris	71 5.7%	4 3.3%	75 5.5%
Other	42 3.4%	3 2.5%	45 3.3%
Complications of Heart Failure (participants) [Number]
Had Heart Failure Complications	16 1.3%	2 1.7%	18 1.3%
Had No Heart Failure Complications	1232 98.7%	118 98.3%	1350 98.7%
New York Heart Association (NYHA) Heart Failure Classification (participants) [Number]
NYHA Class I	15 1.2%	1 0.8%	16 1.2%
NYHA Class II	1 0.1%	1 0.8%	2 0.1%
NYHA Class III	0 0%	0 0%	0 0%
NYHA Class IV	0 0%	0 0%	0 0%
Complications of Stroke-related Disease (participants) [Number]
Had Stroke-related Disease Complication	81 6.5%	7 5.8%	88 6.4%
Had No Stroke-related Disease Complication	1167 93.5%	113 94.2%	1280 93.6%
Breakdown of complications of stroke-related disease (participants) [Number]
Cerebral infarction	80 6.4%	7 5.8%	87 6.4%
Transient ischemic attack	1 0.1%	0 0%	1 0.1%
Complications of Allergic Disease (participants) [Number]
Had Allergic Disease Complication	58 4.6%	7 5.8%	65 4.8%
Had No Allergic Disease Complication	1190 95.4%	113 94.2%	1303 95.2%
Breakdown of Complications of Allergic Disease (participants) [Number]
Asthma bronchial	27 2.2%	3 2.5%	30 2.2%
Pollinosis	12 1%	0 0%	12 0.9%
Rhinitis allergic	25 2%	4 3.3%	29 2.1%
Dermatitis allergic	2 0.2%	0 0%	2 0.1%
Complications of Malignant Tumor (participants) [Number]
Had Malignant Tumor Complications	13 1%	5 4.2%	18 1.3%
Had No Malignant Tumor Complications	1235 99%	115 95.8%	1350 98.7%
Complications of Malignant Tumor (narrow definition) (participants) [Number]
Had Malignant Tumor Complications	11 0.9%	2 1.7%	13 1%
Had No Malignant Tumor Complications	1237 99.1%	118 98.3%	1355 99%
Other Complications (participants) [Number]
Had Other Complications	376 30.1%	34 28.3%	410 30%
Had No Other Complications	872 69.9%	86 71.7%	958 70%
Presence of Medical History (participants) [Number]
Had Presence of Medical History	162 13%	19 15.8%	181 13.2%
Had No Presence of Medical History	960 76.9%	88 73.3%	1048 76.6%
Unknown	126 10.1%	13 10.8%	139 10.2%
History of Allergies (participants) [Number]
Had History of Allergies	78 6.3%	7 5.8%	85 6.2%
Had No History of Allergies	1066 85.4%	95 79.2%	1161 84.9%
Unknown	104 8.3%	18 15%	122 8.9%
History of Alcohol Consumption (participants) [Number]
Had Alcohol Consumption	333 26.7%	34 28.3%	367 26.8%
Had No Alcohol Consumption	690 55.3%	60 50%	750 54.8%
Unknown	225 18%	26 21.7%	251 18.3%
Smoking Classification (participants) [Number]
Never Smoked	525 42.1%	45 37.5%	570 41.7%
Current Smoker	204 16.3%	25 20.8%	229 16.7%
Ex-smoker	233 18.7%	24 20%	257 18.8%
Unknown	286 22.9%	26 21.7%	312 22.8%
Time from Diagnosis of Type 2 Diabetes (participants) [Number]
<2 years	158 12.7%	35 29.2%	193 14.1%
>=2 to <5 years	187 15%	17 14.2%	204 14.9%
>=5 to <10 years	247 19.8%	21 17.5%	268 19.6%
>=10 years	288 23.1%	22 18.3%	310 22.7%
Unknown	368 29.5%	25 20.8%	393 28.7%
Glycosylated Hemoglobin A1c (HbA1c) (participants) [Number]
HbA1c <6.0 percent	30 2.4%	3 2.5%	33 2.4%
HbA1c >=6.0 to <7.0 percent	289 23.2%	27 22.5%	316 23.1%
HbA1c >=7.0 to <8.0 percent	461 36.9%	44 36.7%	505 36.9%
HbA1c >=8.0 percent	365 29.2%	36 30%	401 29.3%
Unknown	103 8.3%	10 8.3%	113 8.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting One or More Adverse Drug Reactions
Description	Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.
Time Frame	Baseline up to 12 months

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who were enrolled and completed the study.

Arm/Group Title	Alogliptin + Thiazolidinedione	Alogliptin + Other
Arm/Group Description	Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
Measure Participants	1248	120
Hypothyroidism	1 0.1%	0 0%
Hyperglycaemia	1 0.1%	0 0%
Hypoglycaemia	5 0.4%	1 0.8%
Dyslipidaemia	1 0.1%	0 0%
Dizziness	3 0.2%	0 0%
Photopsia	1 0.1%	0 0%
Hypertension	1 0.1%	0 0%
Abdominal distension	1 0.1%	0 0%
Diarrhoea	1 0.1%	0 0%
Eczema	1 0.1%	0 0%
Pruritus	1 0.1%	0 0%
Arthralgia	1 0.1%	0 0%
Joint swelling	1 0.1%	0 0%
Local swelling	1 0.1%	0 0%
Pyrexia	1 0.1%	0 0%
Blood insulin decreased	1 0.1%	0 0%
Blood insulin increased	1 0.1%	0 0%
Hand fracture	1 0.1%	0 0%
Rib fracture	1 0.1%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting One or More Serious Adverse Drug Reactions
Description	Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.
Time Frame	Baseline up to 12 months

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who were enrolled and completed the study.

Arm/Group Title	Alogliptin + Thiazolidinedione	Alogliptin + Other
Arm/Group Description	Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
Measure Participants	1248	120
Hyperglycaemia	1 0.1%	0 0%
Hypoglycaemia	2 0.2%	0 0%

3. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c)
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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time Frame	Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)

Outcome Measure Data

Analysis Population Description

The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.

Arm/Group Title	Alogliptin
Arm/Group Description	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
Measure Participants	1129
Baseline (n=1124)	7.67 (1.179)
Change at Month 1 (n=879)	-0.25 (0.597)
Change at Month 3 (n=1005)	-0.47 (0.988)
Change at Month 6 (n=988)	-0.53 (1.098)
Change at Month 12 (n=949)	-0.64 (1.133)
Change at Final assessment (n=1124)	-0.57 (1.143)

4. Secondary Outcome

Title	Percentage of Participants of Achieving Objective Glycemic Control
Description	The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time Frame	Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)

Outcome Measure Data

Analysis Population Description

The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.

Arm/Group Title	Alogliptin
Arm/Group Description	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
Measure Participants	1129
<8.0 percent (Baseline) (n=1124)	68.0 (1.179) 5.4%
<8.0 percent (Month 1) (n=879)	75.8 (0.597) 6.1%
<8.0 percent (Month 3) (n=1005)	84.2 (0.988) 6.7%
<8.0 percent (Month 6) (n=988)	84.5 (1.098) 6.8%
<8.0 percent (Month 12) (n=949)	87.1 (1.133) 7%
<8.0 percent (Final assessment) (n=1124)	83.6 (1.143) 6.7%
<7.0 percent (Baseline) (n=1124)	27.6 2.2%
<7.0 percent (Month 1) (n=879)	34.3 2.7%
<7.0 percent (Month 3) (n=1005)	47.1 3.8%
<7.0 percent (Month 6) (n=988)	51.2 4.1%
<7.0 percent (Month 12) (n=949)	57.5 4.6%
<7.0 percent (Final assessment) (n=1124)	54.2 4.3%
<6.0 percent (Baseline) (n=1124)	2.7 0.2%
<6.0 percent (Month 1) (n=879)	3.2 0.3%
<6.0 percent (Month 3) (n=1005)	5.6 0.4%
<6.0 percent (Month 6) (n=988)	6.8 0.5%
<6.0 percent (Month 12) (n=949)	8.2 0.7%
<6.0 percent (Final assessment) (n=1124)	8.0 0.6%

5. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose
Description	The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time Frame	Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)

Outcome Measure Data

Analysis Population Description

The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.

Arm/Group Title	Alogliptin
Arm/Group Description	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
Measure Participants	1129
Baseline (n=389)	145.4 (41.25)
Change at Month 1 (n=283)	-9.8 (35.39)
Change at Month 3 (n=301)	-11.8 (37.63)
Change at Month 6 (n=297)	-13.9 (41.75)
Change at Month 12 (n=293)	-16.2 (35.46)
Change at Final assessment (n=398)	-13.5 (40.25)

6. Secondary Outcome

Title	Change From Baseline in Fasting Insulin
Description	The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time Frame	Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)

Outcome Measure Data

Analysis Population Description

The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.

Arm/Group Title	Alogliptin
Arm/Group Description	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
Measure Participants	1129
Baseline (n=82)	6.32 (3.121)
Change at Month 1 (n=54)	0.19 (1.519)
Change at Month 3 (n=57)	-0.02 (1.946)
Change at Month 6 (n=60)	0.29 (3.505)
Change at Month 12 (n=68)	-0.32 (1.980)
Change at Final assessment (n=82)	-0.25 (1.951)

Adverse Events

Time Frame	Baseline up to 12 months
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group Title	Alogliptin + Thiazolidinedione		Alogliptin + Other
Arm/Group Description	Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.		Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
All Cause Mortality
	Alogliptin + Thiazolidinedione		Alogliptin + Other
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alogliptin + Thiazolidinedione		Alogliptin + Other
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/1248 (0.2%)		0/120 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	1/1248 (0.1%)		0/120 (0%)
Hypoglycaemia	2/1248 (0.2%)		0/120 (0%)
Other (Not Including Serious) Adverse Events
	Alogliptin + Thiazolidinedione		Alogliptin + Other
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/1248 (0.9%)		2/120 (1.7%)
Metabolism and nutrition disorders
Diabetes mellitus	11/1248 (0.9%)		2/120 (1.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.