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
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone
- Registration Number
- CTRI/2012/12/003247
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 237
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%.
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 patientâ??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) levelsTimepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method 1.Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)Timepoint: 16 weeks;2.Global Assessment of Efficacy by the PhysiciansTimepoint: 16 weeks;3.Global Assessment of Tolerability by the PatientsTimepoint: 16 weeks