Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/26/2017 |
Start Date: | June 20, 2013 |
End Date: | June 1, 2016 |
A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adults Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2
diabetes is non-inferior to Metformin IR monotherapy
diabetes is non-inferior to Metformin IR monotherapy
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Men and women, aged ≥18 years old at time of enrollment
- Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c
≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
- Women must have a negative serum or urine test within 24 hours prior to start of
investigational product
Exclusion Criteria:
- History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
- Symptoms of poorly controlled diabetes, including but not limited to marked polyuria
and polydipsia with >10% weight loss during last 3 months
- Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40
mg/dL (124 μmol/L for female subjects)
We found this trial at
40
sites
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