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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

• Registration Number: CTRI/2012/12/003247
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

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/Metformin or Repaglinide or Metformin IR for sixteen weeks. The prim*a*ry 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.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• 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%.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change in Glycosylated Haemoglobin (HbA1c) levels	16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (27)

AMC MET Medical College, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Apex Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Apex Hospital Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

B.J Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Baroda Medical College & SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

Cosmopolitan Medical Centre; 🇮🇳 Bangalore, KARNATAKA, India

Deogaonkar Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Gandhi Medical College; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Getwell Hospital and Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

IMS & Sum Hospital; 🇮🇳 Khordha, ORISSA, India

Scroll for more (17 remaining)

AMC MET Medical College, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr Hiren Pandya

Principal investigator

917925391810

drhirenpandya@yahoo.com