Study identifier:CV181-014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"
Diabetes Mellitus, Type 2
Phase 3
No
Saxagliptin + Metformin, Placebo + Metformin, Pioglitazone
All
1462
Interventional
18 Years - 77 Years
Allocation: Randomized
Endpoint Classification: Safety/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 clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with 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 pioglitizone added onto their blinded study medication
Location
Location
Buenos Aires, Buenos Aires, Argentina
Location
Mar Del Plata, Buenos Aires, Argentina
Location
Cordoba, Cordoba, Argentina
Location
Rosario, SANTA FE, Argentina
Location
Sydney, New South Wales, Australia
Location
Woollongong, New South Wales, Australia
Location
Kippa Ring, Queensland, Australia
Location
Meadowbrook, Queensland, Australia
Arms | Assigned Interventions |
---|---|
Experimental: Saxagliptin + Metformin (A) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Saxagliptin + Metformin Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
Experimental: Saxagliptin + Metformin (B) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Saxagliptin + Metformin Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
Experimental: Saxagliptin + Metformin (C) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Saxagliptin + Metformin Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
Placebo Comparator: Placebo+ Metformin (D) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Placebo + Metformin Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT) Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
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