| CTRI Number |
CTRI/2014/12/005265 [Registered on: 08/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Ranolazine on control of Diabetes Mellitus |
|
Scientific Title of Study
|
Randomized placebo controlled study of the effect of Ranolazine on HbA1c level in Type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somnath Maity |
| Designation |
resident, Department of Pharmacology |
| Affiliation |
IPGMER, Department of Pharmacology |
| Address |
244B ACHARYA J C BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9163046556 |
| Fax |
|
| Email |
docsom06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Amal Kanti Das |
| Designation |
Professor, Department of Pharmacology |
| Affiliation |
IPGMER, Department of Pharmacology |
| Address |
244B ACHARYA J C BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831728494 |
| Fax |
|
| Email |
profamkd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somnath Maity |
| Designation |
resident, Department of Pharmacology |
| Affiliation |
IPGMER, Department of Pharmacology |
| Address |
244B ACHARYA J C BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9163046556 |
| Fax |
|
| Email |
docsom06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Postgraduate Medical Education Research 244B A J C Bose Road Dept of Pharmacology U C M Building Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER |
| Address |
244B ACHARYA J C BOSE ROAD KOLKATA 700020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Somnath Maity |
Medicine Out Patient Department of Institute of Postgraduate Medical Education and Research |
244B Acharya J. C. Bose Road Kolkata 700020 Division: Department of Medicine and Department of Pharmacology, Medicine Out Patient Department
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9163046556
docsom06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata 700020 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dummy medication with vitamin c tablets |
500 mg BID orally for 12 weeks |
| Intervention |
TABLET RANOLAZINE |
Ranolazine 500 mg BID Orally for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• 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
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline in HbA1c at Week 12
Change from baseline in 2-hour postprandial serum glucose at Week 12
Change from baseline in fasting serum glucose at Week 12
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in fasting serum C-peptide at Weeks 12
Change from baseline in fasting serum insulin at Weeks 12
|
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes mellitus has become endemic in India.
It predisposes to microvascular, macrovascular
complications leading to coronary
syndromes , cerebrovascular accidents, retinopathy, nephropathy, & and many
other diseases.
Ranolazine – a drug approved to be used in coronary
syndromes, showed to improve glycemic control in CARISA TRIAL. Mechanism of
action of glycemic control is yet to be explored.
So a study is planned to evaluate the effect of
ranolazine on HbA1c, fasting glucose, serum insulin, & C-Peptide. The study
design would be a randomized placebo controlled trial. Study population would
be patients attending diabetic clinic of IPGME&R & SSKM Hospital,
Kolkata. Target sample size will be 34 patients in each group suffering from
type 2 Diabetes currently on non-insulin
antidiabetic therapy (Metformin) in
addition to diet and exercise.
After obtaining written informed consent from either
patient, subjects would be randomly allocated to two groups – one to receive
ranolazine and the other to receive placebo as add on to standard oral
hypoglycemic medication (Metformin).
Data would be analyzed in the Department of
Pharmacology, IPGME&R and the results will be compiled into the doctoral
thesis. |