Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Pioglitazone; Saxagliptin

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.

• HbA1c >= 7.0% and <= 10.0 %

• Body mass index <= 40 kg/m2

• Fasting C-peptide >= 1 ng/dL

Exclusion Criteria:

• Symptomatic poorly controlled diabetes

• Recent cardiac or cerebrovascular event

• Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females