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CTRI Number  CTRI/2017/12/010958 [Registered on: 21/12/2017] Trial Registered Prospectively
Last Modified On: 06/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   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.  
Scientific Title of Study   An Open labeled, Non Randomized, Multicentric, Phase IV clinical 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.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MLVGM /01/2016,Version 2.0, Dated 12 June 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjula  
Designation  Vice President, Medical Services  
Affiliation  Micro Labs Limited, Bangalore  
Address  27, Race Course Road, Bangalore KARNATAKA 560001 India

Bangalore
KARNATAKA
560001
India 
Phone  08022370451  
Fax    
Email  drmanjula@microlabs.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjula  
Designation  Vice President, Medical Services  
Affiliation  Micro Labs Limited, Bangalore  
Address  27, Race Course Road, Bangalore KARNATAKA 560001 India

Bangalore
KARNATAKA
560001
India 
Phone  08022370451  
Fax    
Email  drmanjula@microlabs.in  
 
Details of Contact Person
Public Query  
Name  Dr Krishna Kumar M 
Designation  Senior manager- Medical Services 
Affiliation  Micro Labs Limited  
Address  27, Race Course Road, Bangalore KARNATAKA 560001 India

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  krishna@microlabs.in  
 
Source of Monetary or Material Support  
Micro Labs Limited, 27, Race Course Road, Bangalore- 01 
 
Primary Sponsor  
Name  Micro Labs Limited 
Address  27, Race Course Road, Bangalore 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jay Chordia  Fortis JK Hospital  Plot No.1, Shobhagpura, JK Lane, Udaipur, Rajasthan - 313001
Udaipur
RAJASTHAN 		 9928116333

drjaychordia@yahoo.co.in 
Dr Ved Prakash  Indira Gandhi Institute of Medical Sciences  OPD Block, Department of Endocrinology, Sheikhpura, Patna
Patna
BIHAR 		 9472008685

vedprakashims@gmail.com 
Dr Dilip Shah  Indus Diabetes And Obesity Centre  Jain Bhuvan, 60 Feet Rd, Opposite Bavanjinalaya Jain Mandir, Devchand Nagar, Sripal Nagar, Bhayandar West, Thane
Mumbai
MAHARASHTRA 		 9820324286

drshahdilip@yahoo.co.in 
Dr Balamurugan Ramanathan  Kovai Diabetes Speciality Centre & Hospital  No.15, Vivekananda Rd, Peranaidu Layout, Ram Nagar, Coimbatore, Tamil Nadu - 641009
Coimbatore
TAMIL NADU 		 0422-4377732

rbmkdsc@gmail.com 
Dr L Sreenivasa Murthy  Life Care Clinic and Research Centre  2748/2152,M.L.N COMPLEX,16TH E CROSS, 8TH MAIN,D BLOCK,(NEXT TO CORPORATION BANK), Bengaluru, Karnataka - 560092
Bangalore Rural
KARNATAKA 		 9448051046

drlsm@lcrc.in 
Dr N Vijay Kumar  Sri Venkateshwara Hospital  No 86, Hosur Main Road, Madiwala, Bengaluru, Karnataka - 560068
Bangalore Rural
KARNATAKA 		 080-40416789

svhospital1997@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee Indira Gandhi Institute of Medical Sciences  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital  Approved 
Life Care Hospital Institutional Review Board  Approved 
Sri Venkateshwara Hospital Ethics Committee  Approved 
Sri Venkateshwara Hospital Ethics Committee  Approved 
Sri Venkateshwara Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GM1V  The subjects diagnosed with type 2 diabetes mellitus and having uncontrolled diabetes, even after dual therapy of metformin 500mg + glimepiride 1 mg for at least three months along with life style modifications will be initiated with Fixed Dose Combination of Voglibose (0.2 mg) + Glimepiride (1 mg) + Metformin (500 mg) (GM1V) twice daily after meal 
Intervention  GM2V  The patients diagnosed with type 2 diabetes mellitus and having uncontrolled diabetes, even after dual therapy of metformin 500mg + glimepiride 2 mg for at least three months along with life style modifications will be initiated with Fixed Dose Combination of Voglibose (0.2 mg) + Glimepiride (2 mg) + Metformin (500 mg) (GM2V) twice daily after meal 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Male and female Subjects, 18 years of age or older with known case of Type 2 Diabetes Mellitus.
2. 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. 
 
ExclusionCriteria 
Details  1. 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.
6. 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. Subjects unable or unwilling to use acceptable birth control methods
10. Hypersensitivity to any of the components of the formulation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the HbA1C (%) from baseline to end of study  Base line to week 12 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="98" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 11/01/2018 
Date of Study Completion (India) 26/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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

 The Primary outcome of this study was to evaluate the Change in the HbA1C (%) from baseline to end of study

 The Secondary outcome measures included Changes in FPG and 2 hr PPG from baseline at 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 from baseline after end of the study

 The adverse effects of the study drug assessed by monitoring adverse events, vital signs, physical examination and any significant changes in ECG, laboratory parameters.

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

 

 
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