Status:
COMPLETED
Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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)
Key Trial Info
Start Date :
June 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1736 Patients enrolled
Trial Details
Trial ID
NCT01864174
Start Date
June 20 2013
End Date
June 1 2016
Last Update
November 29 2019
Active Locations (156)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209
2
Terence T. Hart, Md
Muscle Shoals, Alabama, United States, 35662
3
Clini Res Advantage Desert Clin Res, Llc
Mesa, Arizona, United States, 85213
4
Clinical Res Advantage Central
Phoenix, Arkansas, United States, 85020