CTRI/2012/12/003247 [Registered on: 20/12/2012] Trial Registered Prospectively
Last Modified On:
26/06/2014
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effect of Fixed Dose Combination of Repaglinide / Metformin IR Tablet in the treatment of patients with Type 2 Diabetes Mellitus
Scientific Title of Study
A Randomized, Double Blind, Comparative, Prospective, Multicentre, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Repaglinide / Metformin IR Tablet Compared with Metformin IR Tablet Monotherapy or Repaglinide Tablet Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2012/005/III; version no.2.0, dated:12.10.2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Piyush Agarwal
Designation
Deputy General Manager
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East), Mumbai
Mumbai MAHARASHTRA 400099 India
Phone
912240189999
Fax
Email
piyusha@glenmarkpharma.com
Details of Contact Person Public Query
Name
Dr Shailendra Sachan
Designation
Manager- Medical Writing
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane MAHARASHTRA 400709 India
Phone
912267720000
Fax
Email
shailendrasachan@glenmarkpharma.com
Source of Monetary or Material Support
Glenmark Pharmaceuticals Ltd
Primary Sponsor
Name
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East), Mumbai, India-400 099
1. Patients aged ≥18 and ≤65 years inclusive of either sex willing to give their written informed consent and comply with the protocol requirements.
2. Patients with Type 2 Diabetes Mellitus who have been treated with Metformin monotherapy for at least 3 months and not adequately controlled.
3. Patients of Type 2 Diabetes Mellitus with Glycosylated Haemoglobin (HbA1c) levels of > 7% to ≤ 9%.
ExclusionCriteria
Details
1. Pregnant or lactating women.
2. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
3. Patients with known hypersensitivity to any of the components of the formulation
4. Known cases of Diabetic Nephropathy, Diabetic Ketoacidosis, Hyperglycemia hyperosmolar state, Retinopathy, Neuropathy or other diabetic complications of sufficient severity to require treatment
5. Clinically significant cardiovascular disease and/or Electrocardiograph abnormality.
6. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
7. Patients with clinically significant Renal, Hepatic, or Cerebrovascular Disease, Malignancy, Chronic Uncontrolled Systemic Diseases like Asthma, Hypertension, Collagen Disorders, etc. or any other serious medical illness.
8. Patients receiving treatment with systemic corticosteroids.
9. Patients who have participated in any clinical trial in the past 1 month.
10. Any other condition that in the opinion of the Investigator that does not justify the patient’s participation in the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean Change in Glycosylated Haemoglobin (HbA1c) levels
16 weeks
Secondary Outcome
Outcome
TimePoints
1. Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)
16 weeks
2. Global Assessment of Efficacy by the Physicians
16 weeks
3. Global Assessment of Tolerability by the Patients
16 weeks
Target Sample Size
Total Sample Size="237" Sample Size from India="237" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is double-blind, randomized, active controlled, three-arm, parallel-group, comparative study. Study will enroll 237 patients with type 2 diabetes from the different centers from India.
Patients will be recruited after providing written informed consent. After successful screening, patients will be randomized in 1:1:1 ratio to receive either Fixed Dose Combination of Repaglinide/Metforminor Repaglinide or Metformin IR for sixteen weeks. The primary objective of the study is to see the mean Change in Glycosylated Haemoglobin (HbA1c) levels. Secondary objective includes fasting and postprandial plasma glucose, Global Assessment of Efficacy by the Physicians and Global Assessment of Tolerability by the Patient.
During the study, there will be 6 study visits for efficacy, safety and tolerability assessment.