A Clinical Trial to evaluate the efficacy and safety of a fixed dose combination of two antidiabetic drugs, Repaglinide and metformi
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2011/05/001728
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 234
1.Patients with Type 2 Diabetes Mellitus not satisfactorily managed with diet and exercise therapy alone for 3 months or Patients with Type 2 Diabetes Mellitus not adequately controlled with 1 to 1.5 grams per day of Metformin Monotherapy
2.Age Between 18 to 75 years
3.Males and non-pregnant females (with negative ï?¢ human Chorionic Gonadotropin test or Urine Pregnancy test).
4.Female patients on adequate contraceptive control
5.Patients with Type 2 Diabetes Mellitus fulfilling the following baseline laboratory criteria:
�Fasting Plasma Glucose (FPG) concentrations between 140 and 250 mg/dl
�Glycosylated Haemoglobin (HbA1c) levels of 7%- 11%.
6.Patients with a body mass index (BMI) 20, calculated as weight in kilograms divided by the square of height in meters,
7.Patients willing to give their written informed consent
8.Patients willing to comply with the protocol requirements
1.Patients with Type 1 Diabetes Mellitus
2.Type 2 Diabetes Mellitus Patients treated with Insulin for more than 14 days and
3.Patients with satisfactory diabetes control with HbA1c 7% in last 12 weeks.
4.Pregnant and nursing women or females of child bearing potential using inadequate contraceptive measures before or during the trial.
5.Known cases of Diabetic Nephropathy, Retinopathy, Neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis.
6.New York Heart Association (NYHA) Classification Category III and IV Cardiac Insufficiency, Ischaemic Heart Disease, Coronary Insufficiency or any other clinically significant cardiovascular disease.
7.Electrocardiograph evidence of Left Ventricular Hypertrophy (LVH) or other cardiac abnormalities including Left Ventricular Failure (LVF)
8.Patients having history of Hypersensitivity or Allergy to Metformin and /or Repaglinide and / or drugs belonging to similar classes of Antidiabetic drugs.
9.Patients who would require chronic Insulin therapy or concomitant therapy with Anorectic agents like Phenteramine Hydrochloride, Dexfenfluramine Hydrochloride, or Fenfluramine Hydrochloride.
10.Immunocompromised status and patients with uncontrolled Systemic Infections.
11.Patients with history of uncontrolled Hypertension of Systolic Blood Pressure 160 mm Hg and /or Diastolic Blood Pressure of 105 mm Hg.
12.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.
13.Renal abnormalities as defined by Serum Creatinine 1.4 mg/dL for males and 1.3 mg/dL for females
14.Liver abnormalities as defined by elevated SGOT & SGPT 2.5 times of the upper limit of normal (ULN) range or Serum Bilirubin 2 times of the upper limit of normal range.
15.Patients receiving treatment with systemic corticosteroids.
16.Patients with history of 3 episodes of Hypoglycemia within past 6 months which were clinically significant requiring hospitalization or third party assistance.
17.Patients who had participated in any Repaglinide or Metformin or Sulfonylurea related study, or used any Investigational Drug in the past 3 months of the study.
18.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 To evaluate and compare the Mean Percentage Change in Glycosylated Haemoglobin <br/ ><br> (HbA1c) levels from baseline to the end of the treatment (Week 16) between the three Treatment groups. <br/ ><br>Timepoint: To evaluate and compare the Mean Percentage Change in Glycosylated Haemoglobin <br/ ><br> (HbA1c) levels from baseline to the end of the treatment (Week 16) between the three Treatment groups. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To assess and compare the proportion of cases with ≤7.0% HbA1c level at the end of treatment between and within treatment groups <br/ ><br>2.?To Estimate and Compare the Mean Change between Treatment groups for Secondary VariablesTimepoint: Baseline and end of study