This study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus Patients
- Registration Number
- CTRI/2010/091/002997
- Lead Sponsor
- Johnson Johnson Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 720
Inclusion Criteria
Adult Male or females aged between 55 to 80 years of age with diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
Patients in the study must have a HbA1c between greater ot equal to 7 and less than or equal to 10 percent.
Patients must have a fasting plasma glucose (FPG) less than 270 mg/dL (15 mmol/L)
Exclusion Criteria
History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) in the main study.Timepoint: After 26 weeks of treatment with study drug
- Secondary Outcome Measures
Name Time Method To assess the effect of study drug on body composition (eg total fat mass) as measured by DXATimepoint: After 26 weeks of treatment;To assess the effect of study drug on bone mineral density as measured by dual-energy X-ray absorptiometry (DXA)Timepoint: After 26, 52 and 104 weeks of treatment with study drug;To assess the effect of study drug on bone strength as measured by Quantitative Computerized Tomography (QCT) in a subgroup of patientsTimepoint: After 52 weeks of treatment;To assess the effect of study drug on markers of bone turnoverTimepoint: After 12 and 26 weeks of treatment