A Multicentric, Randomized, Open Label, Comparative, Parallel assignment Clinical Trial to Evaluate the Safety and Efficacy of Fixed Dose Combinations (FDC) of Repaglinide (0.5mg / 1mg) + Voglibose (0.2mg / 0.3mg) tablets Versus Repaglinide (0.5mg / 1mg) tablets in Patients with Type 2 Diabetes Mellitus
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT/REPA VOGL/DIA/14 Version 2.1 dated 02/07/16
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Sushil Kumar Anand
Designation
Assistant General Manager
Affiliation
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Address
Torrent Pharmaceuticals Ltd,
Research centre,
Village: bhat-382 428
Dist: gandhinagar, gujarat
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Repaglinide 0.5mg and 1.0mg Tablets
3 times a day orally, within 15 minutes prior to the meal.
Patients will be instructed to skip a dose in case of skipped meal.
Intervention
[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]. FDC of Repaglinide (1.0 mg) & Voglibose (0.3mg) tablet
3 times a day orally, within 15 minutes prior to the meal. Patients will be instructed to skip a dose in case of skipped meal
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean change in glycosylated hemoglobin (HbA1C) from baseline (screening) to end of treatment period.
Week 0, Week 12, Week 24
Secondary Outcome
Outcome
TimePoints
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.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Type 2 diabetes is a chronic, progressive metabolic disease defined by the presence of chronic hyperglycemia. To overcome high failure rate of long-term monotherapy and progression of vascularcomplications developed due to postprandial glucose excursions, a combined therapy of oral antidiabetic agents with complementary modes of action should be considered. Because of their complementary mechanism of actions, combination therapy with non-sulfonylurea insulin secretagogue (repaglinide) with alpha -glucosidase inhibitor (voglibose) will will have synergistic action in patient with post prandial hyperglycemia. Considering this Phase III clinical trialhas been planned to evaluate safety and efficacy of fixed dose combinations of Repaglinide + Voglibose in patients with type 2 diabetes.