This study is to check the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with type 2 diabetes
- Conditions
- Type 2 diabetes mellitus (T2DM)
- Registration Number
- CTRI/2010/091/000595
- Brief Summary
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of JNJ-28431754 (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.We intend to recruit 200 patients from India and first patient consented in India is planned on 21 June 2010.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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 A1c From baseline through Week 52
- Secondary Outcome Measures
Name Time Method The percent change in body weight From baseline through Week 52
Trial Locations
- Locations (10)
AVBR Hospital
🇮🇳Wardha, MAHARASHTRA, India
Deenanath Mangeshkar Hospital
🇮🇳Pune, MAHARASHTRA, India
Diabetomics India Pvt. Ltd
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr. V. Seshiah Diabetes Research Institute & Dr. Balaji Diabetes Care Centre
🇮🇳Chennai, TAMIL NADU, India
Gandhi's Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
Institute of Clinical Endocrinology & Diabetes Care Unit
🇮🇳Nagpur, MAHARASHTRA, India
Jnana Sanjeevini Medical Center,
🇮🇳Bangalore, KARNATAKA, India
Kovai Diabetes Speciality Center and Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Medisys Clinisearch India Pvt. Ltd.,
🇮🇳Bangalore, KARNATAKA, India
Osmania General Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
AVBR Hospital🇮🇳Wardha, MAHARASHTRA, IndiaDr. Satish MahajanPrincipal investigatormahajandr@rediffmail.com