Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease
Phase 3
Completed
- Conditions
- Health Condition 1: null- Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control.Health Condition 2: E112- Type 2 diabetes mellitus with kidney complications
- Registration Number
- CTRI/2009/091/000140
- Lead Sponsor
- Merck Sharp and Dohme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Patient has type 2 diabetes mellitus
Patient is on dialysis.
Exclusion Criteria
Patient has type 1 diabetes mellitus or a history of ketoacidosis
Patient is on a new weight loss program
Patient has active liver disease
Patient has been on dialysis for less than 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks)Timepoint: [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG dataTimepoint: Time Frame: At the end of 54 weeks [ Designated as safety issue: No ] <br/ ><br>