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 115 investigative sites in Australia, Brazil, Chile, Germany, Guatemala, Hungary, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 10 March 2006 to 12 June 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 who were inadequately controlled while receiving a stable dose of metformin monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.

Reporting Groups

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

Participant Flow:   Overall Study

	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Placebo
STARTED	213	210	104
COMPLETED	176	165	72
NOT COMPLETED	37	45	32
Hyperglycemic Rescue	19	17	25
Adverse Event	7	6	1
Protocol Violation	2	4	2
Lost to Follow-up	5	2	1
Physician Decision	1	1	1
Administrative Error	1	1	0
Withdrawal by Subject	2	14	2

Reporting Groups

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

Baseline Measures

	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Placebo	Total
Number of Participants   [units: participants]	213	210	104	527
Age, Customized   [units: participants]
<65 years	173	179	83	435
≥65 years	40	31	21	92
Gender   [units: participants]
Female	112	96	54	262
Male	101	114	50	265

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. ]