Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: [1]. FDC of Repaglinide (0.5mg) & Voglibose (0.2mg) tablet
[2]. FDC of Repaglinide (1.0mg) & Voglibose (0.2 mg)tablet
[3]. FDC of Repaglinide (0.5mg) & Voglibose (0.3mg)tablet
[4]. F
Sponsors
Torrent Pharamceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus. 2.Patients who are inadequately controlled (HbA1C >= 7.0%) with metformin monotherapy at maximum tolerable stable dose (not less than 1000mg/day) for at least 1 month prior to screening. 3.Patients who have 2hr Post Prandial Glucose >= 200mg/dl at screening visit. 4.Patients willing to give informed consent
Exclusion criteria
Exclusion criteria: 1.Patients with Insulin Dependent Diabetes Mellitus (IDDM). 2.Patients with Fasting Plasma Glucose (FPG) >= 200 mg/dl and/or Glycosylated Hemoglobin (HbA1C) >= 9%. 3.Patients requires frequent insulin for adequate glycemic control 4.Patients with history of treatment failure or intolerance or hypersensitivity with meglitinides and/or alpha-glucosidase inhibitors. 5.Patients with history of acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 6.Patients with history of inflammatory bowel disease, colonic ulcerations or intestinal obstructions. 7.Patients who are known seropositive cases of HIV, Hepatatis B or Hepatitis C. 8.Patients with clinically significant impaired renal or hepatic function. [Aspartate aminotransferase (AST) & Alanine transaminase(ALT) more than 2.5X the UNL and/or bilirubin more than 1.5X the UNL and/or serum creatinine >1.5 mg/dl.] 9.Patients planning to undergo any surgical procedure during their participation in the study (except minor procedures not associated with restricted intake of food and fluids). 10.History of malignancy in last 5 years. 11.Patients with history of alcohol or drug abuse. 12.Clinically Significant abnormal physical, laboratory, ECG findings and/or any other clinical condition or history at the screening examination, which would interfere with the study objectives. 13.Patients on any medications (other than metformin) which may interfere with study outcome. 14.History of angina, Myocardial Infarction (MI) or stroke within last 6 months prior to screening. 15.Pregnant or lactating women. 16.Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device) 17.Intake of any investigational drug within 3 months prior to the first dose of study drug 18.In the opinion of the investigator, patient is unable to cooperate with any study procedures, unlikely to adhere to the study protocol, keep appointments, or is planning to relocate during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated hemoglobin (HbA1C) from baseline (screening) to end of treatment period.Timepoint: Week 0, Week 12, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in fasting plasma glucose (FPG) from baseline (screening) to end of treatment period. 2.Mean change in 2-hr post prandial plasma glucose (PPG) from baseline (screening) to end of treatment period.Timepoint: Week 0, Week 2, Week 4, Week 8, Week 12, Week 18 and Week 24 | — |
Countries
India
Contacts
Public ContactDr Sushil Kumar Anand
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Outcome results
None listed