Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
Saxagliptin 10 mg	The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
Metformin	The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.

Participant Flow:   Overall Study

	Saxagliptin 5 mg + Metformin	Saxagliptin 10 mg + Metformin	Saxagliptin 10 mg	Metformin
STARTED	320	323	335	328
Completed Study Without Being Rescued	179	177	113	144
COMPLETED	229	231	209	219
NOT COMPLETED	91	92	126	109
Lack of Efficacy	18	18	35	29
Withdrawal of Consent by Subject	20	24	28	25
Lost to Follow-up	22	23	29	22
Adverse Event	14	10	14	14
Subject no longer meets study criteria	4	2	8	7
Poor/Noncompliance	11	8	4	5
Physician Decision	0	1	3	2
Death	1	2	2	3
Pregnancy	0	2	1	1
Administrative Reason by Sponsor	1	2	2	1

Reporting Groups

	Description
Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
Saxagliptin 10 mg	The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
Metformin	The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.

Baseline Measures

	Saxagliptin 5 mg + Metformin	Saxagliptin 10 mg + Metformin	Saxagliptin 10 mg	Metformin	Total
Number of Participants   [units: participants]	320	323	335	328	1306
Age   [units: years] Mean ± Standard Deviation	51.95  ± 10.43	52.08  ± 11.59	52.09  ± 10.17	51.83  ± 10.74	51.99  ± 10.73
Gender   [units: participants]
Female	155	177	166	165	663
Male	165	146	169	163	643

1.  Primary:

Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy   [ Time Frame: Baseline, Week 24 ]

2.  Primary:

Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy   [ Time Frame: Week 24 ]

6.  Secondary:

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy   [ Time Frame: Week 24 ]

7.  Secondary:

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy   [ Time Frame: Baseline, Week 24 ]

9.  Secondary:

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy   [ Time Frame: Week 24 ]

10.  Secondary:

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy   [ Time Frame: Week 24 ]

11.  Secondary:

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy   [ Time Frame: Week 24 ]

12.  Secondary:

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy   [ Time Frame: Week 24 ]