A study to evaluate the safety and efficacy of triple drug combination of Voglibose 0.2 mg, Glimepiride 1mg / 2mg and Metformin 500 mg in patients with type 2 diabetes mellitus inadequately controlled with dual therapy.

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: CTRI/2017/12/010958
• Lead Sponsor: Micro Labs Limited

Brief Summary

This isan Open labeled, Non Randomized, Multicentric, Phase IV clinical study toevaluate the safety and efficacy of triple drug combination of Voglibose 0.2mg, Glimepiride 1mg / 2mgand Metformin 500 mg in patients with type 2 diabetesmellitus inadequately controlled with dual therapy

ThePrimary outcome of this study was to evaluate the Change in the HbA1C (%) frombaseline to end of study

TheSecondary outcome measures included Changes in FPG and 2 hr PPG from baselineat week-2, week-4, week-8 and week-12, Change in the lipid variables (TC, TG,LDL-C, HDL-C) (Baseline vs end of the study), Change in body weight frombaseline after end of the study

Theadverse effects of the study drug assessed by monitoring adverse events, vitalsigns, physical examination and any significant changes in ECG, laboratoryparameters.

Theresults confirm that the combination of Voglibose (0.2 mg) +Glimepiride (1/2mg) +Metformin SR (500 mg) is effective, safe and well tolerated.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study Completion: 2019-08-26
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male and female Subjects, 18 years of age or older with known case of Type 2 Diabetes Mellitus.
• Subjects must have an glycated (or glycosylated) haemoglobin (HbA1c) > 7 % despite dual therapy (Metformin 500 mg + Glimepiride 1/2 mg) 3.
• Subjects Uncontrolled on and life style modifications interventions 4.
• Subjects who have HbA1c >9% and are naïve to treatment 5.
• Willing to complete all study-related procedures 6.
• Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed.

Exclusion Criteria

• Subjects with history of Type I Diabetes Mellitus (DM) or a secondary form of diabetes (Diabetes caused by the pancreatic diseases) 2.
• Subjects with a medical history of unstable angina, or heart failure (New York Heart Association class III-IV) or any clinically significant electrocardiogram (ECG) abnormalities such as ventricular tachycardia or a medical history of ventricular tachycardia 3.
• Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty within the last 12 months 4.
• Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation 5.
• Participation in another trial with an investigational drug within 2 months prior to informed consent.
• The subject has diastolic blood pressure > 100 millimeters of mercury (mmHg) and/or systolic blood pressure >180 mmHg 7.
• Subjects having high triglyceride levels > 500 milligram/decilitre (mg /dl) 8.
• Women who are pregnant or breastfeeding 9.
• Hypersensitivity to any of the components of the formulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the HbA1C (%) from baseline to end of study	Base line to week 12

Secondary Outcome Measures

Name	Time	Method
Changes in Fasting Plasma Glucose (FPG) and 2 hour Postprandial Plasma Glucose (PPG) from Baseline to Week 12	Baseline, week-2, week-4, week-8 and week-12
Change in the lipid variables from baseline to end of the study (Total cholesterol, Triglycerides, LDL-C, HDL-C)	Baseline and week 12
Change in body weight from Baseline to end of the study	Baseline and week 12
Safety and tolerability : The adverse effects of the study drug will be assessed by monitoring adverse events, vital signs, physical examination and clinically significant changes in laboratory parameters	Baseline to end of the study

Trial Locations

Locations (6)

Fortis JK Hospital; 🇮🇳 Udaipur, RAJASTHAN, India

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Indus Diabetes And Obesity Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Kovai Diabetes Speciality Centre & Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Life Care Clinic and Research Centre; 🇮🇳 Rural, KARNATAKA, India

Sri Venkateshwara Hospital; 🇮🇳 Rural, KARNATAKA, India

Fortis JK Hospital

🇮🇳Udaipur, RAJASTHAN, India

Dr Jay Chordia

Principal investigator

9928116333

drjaychordia@yahoo.co.in