Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at 125 investigative sites in 13 countries from 24 February 2006 to 02 August 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of 3, once-daily (QD) treatment groups.

Reporting Groups

	Description
Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Participant Flow:   Overall Study

	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
STARTED	97	197	199
COMPLETED	71	153	160
NOT COMPLETED	26	44	39
Hyperglycemic rescue	12	19	18
Withdrawal by Subject	2	10	9
Adverse Event	3	8	6
Physician Decision	5	5	1
Lost to Follow-up	3	1	3
Protocol Violation	1	1	2

Reporting Groups

	Description
Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Total
Number of Participants   [units: participants]	97	197	199	493
Age, Customized   [units: participants]
<65 years	83	165	160	408
Between 65 and 74 years	10	29	34	73
≥75 years	4	3	5	12
Gender   [units: participants]
Female	44	88	74	206
Male	53	109	125	287

1.  Primary:

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.   [ Time Frame: Baseline and Week 26. ]

2.  Secondary:

Change From Baseline in Glycosylated Hemoglobin (Week 4).   [ Time Frame: Baseline and Week 4. ]

3.  Secondary:

Change From Baseline in Glycosylated Hemoglobin (Week 8).   [ Time Frame: Baseline and Week 8. ]

4.  Secondary:

Change From Baseline in Glycosylated Hemoglobin (Week 12).   [ Time Frame: Baseline and Week 12. ]

5.  Secondary:

Change From Baseline in Glycosylated Hemoglobin (Week 16).   [ Time Frame: Baseline and Week 16. ]

6.  Secondary:

Change From Baseline in Glycosylated Hemoglobin (Week 20).   [ Time Frame: Baseline and Week 20. ]

7.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 1).   [ Time Frame: Baseline and Week 1. ]

8.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 2).   [ Time Frame: Baseline and Week 2. ]

9.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 4).   [ Time Frame: Baseline and Week 4. ]

10.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 8).   [ Time Frame: Baseline and Week 8. ]

11.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 12).   [ Time Frame: Baseline and Week 12. ]

12.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 16).   [ Time Frame: Baseline and Week 16. ]

13.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 20).   [ Time Frame: Baseline and Week 20. ]

14.  Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 26).   [ Time Frame: Baseline and Week 26. ]

15.  Secondary:

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).   [ Time Frame: 26 Weeks. ]

16.  Secondary:

Number of Participants Requiring Rescue.   [ Time Frame: 26 Weeks. ]

17.  Secondary:

Change From Baseline in Fasting Proinsulin (Week 4).   [ Time Frame: Baseline and Week 4. ]

18.  Secondary:

Change From Baseline in Fasting Proinsulin (Week 8).   [ Time Frame: Baseline and Week 8. ]

19.  Secondary:

Change From Baseline in Fasting Proinsulin (Week 12).   [ Time Frame: Baseline and Week 12. ]

20.  Secondary:

Change From Baseline in Fasting Proinsulin (Week 16).   [ Time Frame: Baseline and Week 16. ]

21.  Secondary:

Change From Baseline in Fasting Proinsulin (Week 20).   [ Time Frame: Baseline and Week 20. ]

22.  Secondary:

Change From Baseline in Fasting Proinsulin (Week 26).   [ Time Frame: Baseline and Week 26. ]

23.  Secondary:

Change From Baseline in Insulin (Week 4).   [ Time Frame: Baseline and Week 4. ]

24.  Secondary:

Change From Baseline in Insulin (Week 8).   [ Time Frame: Baseline and Week 8. ]

25.  Secondary:

Change From Baseline in Insulin (Week 12).   [ Time Frame: Baseline and Week 12. ]

26.  Secondary:

Change From Baseline in Insulin (Week 16).   [ Time Frame: Baseline and Week 16. ]

27.  Secondary:

Change From Baseline in Insulin (Week 20).   [ Time Frame: Baseline and Week 20. ]

28.  Secondary:

Change From Baseline in Insulin (Week 26).   [ Time Frame: Baseline and Week 26. ]

29.  Secondary:

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).   [ Time Frame: Baseline and Week 4. ]

30.  Secondary:

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).   [ Time Frame: Baseline and Week 8. ]

31.  Secondary:

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).   [ Time Frame: Baseline and Week 12. ]

32.  Secondary:

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).   [ Time Frame: Baseline and Week 16. ]

33.  Secondary:

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).   [ Time Frame: Baseline and Week 20. ]

34.  Secondary:

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).   [ Time Frame: Baseline and Week 26. ]

35.  Secondary:

Change From Baseline in C-peptide (Week 4).   [ Time Frame: Baseline and Week 4. ]

36.  Secondary:

Change From Baseline in C-peptide (Week 8).   [ Time Frame: Baseline and Week 8. ]

37.  Secondary:

Change From Baseline in C-peptide (Week 12).   [ Time Frame: Baseline and Week 12. ]

38.  Secondary:

Change From Baseline in C-peptide (Week 16).   [ Time Frame: Baseline and Week 16. ]

39.  Secondary:

Change From Baseline in C-peptide (Week 20).   [ Time Frame: Baseline and Week 20. ]

40.  Secondary:

Change From Baseline in C-peptide (Week 26).   [ Time Frame: Baseline and Week 26. ]

41.  Secondary:

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.   [ Time Frame: Baseline and Week 26. ]

42.  Secondary:

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.   [ Time Frame: Baseline and Week 26. ]

43.  Secondary:

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.   [ Time Frame: Baseline and Week 26. ]

44.  Secondary:

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.   [ Time Frame: Baseline and Week 26. ]

45.  Secondary:

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.   [ Time Frame: Baseline and Week 26. ]

46.  Secondary:

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.   [ Time Frame: Baseline and Week 26. ]

47.  Secondary:

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.   [ Time Frame: Baseline and Week 26. ]

48.  Secondary:

Change From Baseline in Body Weight (Week 8).   [ Time Frame: Baseline and Week 8. ]

49.  Secondary:

Change From Baseline in Body Weight (Week 12).   [ Time Frame: Baseline and Week 12. ]

50.  Secondary:

Change From Baseline in Body Weight (Week 20).   [ Time Frame: Baseline and Week 20. ]

51.  Secondary:

Change From Baseline in Body Weight (Week 26).   [ Time Frame: Baseline and Week 26. ]