Effect of Ranolazine on control of Diabetes Mellitus
Phase 3
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2014/12/005265
- Lead Sponsor
- IPGMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
•18 to65 years old
•Subjects with T2DM currently on non-insulin antidiabetic therapy (metformin) in addition to diet and exercise
•Body mass index (BMI) >= 20 kg/m2 and <= 35 kg/m2
•HbA1c 7 - 10%
•Female of child-bearing potential must agree to use effective methods of contraception
•Signed written informed consent
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at Week 12 <br/ ><br>Change from baseline in 2-hour postprandial serum glucose at Week 12 <br/ ><br>Change from baseline in fasting serum glucose at Week 12 <br/ ><br>Timepoint: 12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change from baseline in fasting serum C-peptide at Weeks 12 <br/ ><br>Change from baseline in fasting serum insulin at Weeks 12 <br/ ><br>Timepoint: 12 WEEKS