Safety and Efficacy of Fixed Dose Combinations of Repaglinide and Voglibose tablets in Patients with Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 diabetes mellitus with unspecified complications,

Registration Number: CTRI/2017/01/007651

Lead Sponsor: Torrent Pharamceutical Ltd

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 vascular complications 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 trial has been planned to evaluate safety and efficacy of fixed dose combinations of Repaglinide **+** Voglibose in patients with type 2 diabetes.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 210

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 â‰¥ 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 â‰¥ 200mg/dl at screening visit.
4.Patients willing to give informed consent.

Exclusion Criteria

1.Patients with Insulin Dependent Diabetes Mellitus (IDDM).
2.Patients with Fasting Plasma Glucose (FPG) â‰¥ 200 mg/dl and/or Glycosylated Hemoglobin (HbA1C) â‰¥ 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in glycosylated hemoglobin (HbA1C) from baseline (screening) to end of treatment period.	Week 0, Week 12, Week 24

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (23): B. J. Medical College and Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
BAPS Pramukhswami Hospital
🇮🇳
Surat, GUJARAT, India
BSES Municipal General Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Dayanand Medical College & Hospital
🇮🇳
Ludhiana, PUNJAB, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
🇮🇳
Lucknow, UTTAR PRADESH, India
Fortis Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Grant Government Medical College & J. J. Group of Hospitals
🇮🇳
Mumbai, MAHARASHTRA, India
Institute of Medical Sciences & SUM Hospital
🇮🇳
Khordha, ORISSA, India
Institute of Post-Graduate Medical Education and Research
🇮🇳
Kolkata, WEST BENGAL, India
King Georges Medical University
🇮🇳
Lucknow, UTTAR PRADESH, India
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B. J. Medical College and Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Bhagirath Solanki
Principal investigator
9904025799
drbhagirath@yahoo.co.in