Effect of Ranolazine on control of Diabetes Mellitus

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: CTRI/2014/12/005265
• Lead Sponsor: IPGMER

Brief Summary

Diabetes mellitus has become endemic in India.It predisposes to microvascular, macrovascular complications leading to  coronarysyndromes , cerebrovascular accidents, retinopathy, nephropathy, & and manyother diseases.

Ranolazine – a drug approved to be used in coronarysyndromes, showed to improve glycemic control in CARISA TRIAL. Mechanism ofaction of glycemic control is yet to be explored.

So a study is planned to evaluate the effect ofranolazine on HbA1c, fasting glucose, serum insulin, & C-Peptide. The studydesign would be a randomized placebo controlled trial. Study population wouldbe patients attending diabetic clinic of IPGME&R & SSKM Hospital,Kolkata. Target sample size will be 34 patients in each group suffering fromtype 2 Diabetes currently on  non-insulinantidiabetic therapy (Metformin)  inaddition to diet and exercise.

After obtaining written informed consent from eitherpatient, subjects would be randomly allocated to two groups – one to receiveranolazine and the other to receive placebo as add on to standard oralhypoglycemic medication (Metformin).

Data would be analyzed in the Department ofPharmacology, IPGME&R and the results will be compiled into the doctoralthesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 2014-11-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• 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 2-hour postprandial serum glucose at Week 12	12 weeks
Change from baseline in fasting serum glucose at Week 12	12 weeks
Change from baseline in HbA1c at Week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fasting serum C-peptide at Weeks 12	Change from baseline in fasting serum insulin at Weeks 12

Trial Locations

Locations (1)

Medicine Out Patient Department of Institute of Postgraduate Medical Education and Research; 🇮🇳 Kolkata, WEST BENGAL, India

Medicine Out Patient Department of Institute of Postgraduate Medical Education and Research

🇮🇳Kolkata, WEST BENGAL, India

Somnath Maity

Principal investigator

9163046556

docsom06@gmail.com