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
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
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
Inclusion Criteria:
Exclusion Criteria:
Belgrano, Buenos Aires C1426EGP, Argentina
Buenos Aires, Buenos Aires 1121, Argentina
Buenos Aires, Buenos Aires B7602CBM, Argentina
Buenos Aires, Buenos Aires C1117ABH, Argentina
Buenos Aires, Buenos Aires C1425AGC, Argentina
Capital Federal, Buenos Aires 1221, Argentina
Capital Federal, Buenos Aires C1406GWY, Argentina
Lanus Este, Tucumán Province 1824, Argentina
Panjagutta, Hyderabad, Andhra Pradesh 500082, India
Kandivili West, Mumbai 400067, India
Sarita Vihar, New Delhi 110076, India
Rajasthan, 302001, India
Rajasthan, 334 003, India
Michalow-Regionow, 05-119, Poland
Rio Pieoras, 00926, Puerto Rico
Saint Peterburg, 195257, Russia
Tuymen, 625023, Russia
Yaroslaval, 150003, Russia
Dniepropetrovsk, 49044, Ukraine