This study is to check the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with type 2 diabetes
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitus (T2DM)
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1281
Patients must have a diagnosis of type 2 diabetes
Body mass index (BMI) more than or equal to 22 to less than or equal to 45 kg per sqm at screening
Patients must be taking a stable dosage of metformin as monotherapy at screening
Patients must have a HbA1c between more than or equal to 7percent and less than or equal to 9.5percent at Week 2
Patients must have a fasting plasma glucose (FPG) less than or equal to 270 mgperdL ie 15 mmolperL at Week -2
Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
History of diabetic ketoacidosis or type 1 diabetes mellitus
History of pancreas or beta-cell transplantation
History of active proliferative diabetic retinopathy
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
Taken thiazolidinedione therapy in the past 16 weeks before screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is the change in Hemoglobin A1cTimepoint: From baseline through Week 52
- Secondary Outcome Measures
Name Time Method The percent change in body weightTimepoint: From baseline through Week 52