Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3

Completed

Brief Summary: The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Detailed Description: All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo (E)	Placebo	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QAM (C)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QPM (D)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg QAM (A)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QAM (C)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg QAM (A)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Placebo (E)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QPM (D)	metformin	PLUS open-label metformin (as needed as rescue medication)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1 (A1C) at Week 24	Baseline, Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving A1C < 7% at Week 24	Week 24	Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24	Baseline, Week 24	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM	Baseline, Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline, Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.

Locations (51): Tomac, Inc.
🇺🇸
Columbiana, Alabama, United States
Winston Technology, Inc.
🇺🇸
Haleyville, Alabama, United States
Clinical Reseacrh Advantage/ Brown Family Medicine
🇺🇸
Mesa, Arizona, United States
Strategos Medical Group
🇺🇸
Bakersfield, California, United States
Providence Clinical Research
🇺🇸
Burbank, California, United States
Rx For Life, Inc
🇺🇸
Cudahy, California, United States
Medical Group Of Encino
🇺🇸
Encino, California, United States
Southland Clinical Research Center, Inc.
🇺🇸
Fountain Valley, California, United States
Valley Research
🇺🇸
Fresno, California, United States
Diabetes Medical Center Of California
🇺🇸
Northridge, California, United States
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Tomac, Inc.
🇺🇸Columbiana, Alabama, United States