Study identifier:CV181-039
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control
diabetes
Phase 3
No
Saxagliptin, Metformin, Placebo, pioglitazone
All
1306
Interventional
18 Years - 77 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
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 pioglitazone (rescue medication) added onto their blinded study medication
Location
Location
Midland, TX, United States, 79705
Location
New Braunfels, TX, United States, 78130
Location
Indianapolis, IN, United States, 46250
Location
Chicago, IL, United States, 60607
Location
Mentor, OH, United States, 44060
Location
Santa Monica, CA, United States, 90404
Location
Fayetteville, TN, United States, 37334
Location
Greer, SC, United States, 29651
Arms | Assigned Interventions |
---|---|
Experimental: Saxagliptin and Metformin (A) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Saxagliptin Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
Experimental: Saxagliptin and Metformin (B) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Saxagliptin Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
Experimental: Saxagliptin and Placebo (C) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Saxagliptin Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: Placebo Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
Active Comparator: Metformin and Placebo (D) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: Placebo Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
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