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CTRI Number  CTRI/2021/04/033194 [Registered on: 28/04/2021] Trial Registered Prospectively
Last Modified On: 07/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, Metformin Immediate Release and Metformin Extended Release in newly diagnosed type 2 diabetes mellitus patients. 
Scientific Title of Study   A study to evaluate the efficacy and safety of metformin immediate release versus metformin extended release in drug naive patients with type 2 diabetes mellitus: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Syed Salman Farookh 
Designation  Post graduate Pharmacology 
Affiliation  Bangalore Medical College and Research Institute 
Address  Bangalore Medical College and Research Institute, KR road Fort Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9590292666  
Fax    
Email  ssfarookh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Laxminarayana Kamath 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Bangalore Medical College and Research Institute KR road Fort Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone    
Fax    
Email  lkamathbmcri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Syed Salman Farookh 
Designation  Post graduate Pharmacology 
Affiliation  Bangalore Medical College and Research Institute 
Address  Bangalore Medical College and Research Institute KR road Fort Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9590292666  
Fax    
Email  ssfarookh@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, Bengaluru 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute 
Address  Bangalore Medical College and Research Institute, Bengaluru-560002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Syed Salman Farookh  Victoria Hospital  Department of Medicine, 1st floor, Victoria Hospital, KR road, Bengaluru-560002
Bangalore
KARNATAKA 		 9590292666

ssfarookh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute, IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Metformin Extended Release(XR)  Metformin XR 1000 mg tablet orally once daily with evening meal 
Comparator Agent  Metformin immediate release(IR)  Metformin IR 500mg tablet orally twice daily with meal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Newly diagnosed Type 2 Diabetes Mellitus Patients as per American Diabetes Association guidelines.3
2. Patients of either sex aged ≥18years to ≤60 years.
3. Patients willing to give written informed consent.
 
 
ExclusionCriteria 
Details  1. Newly diagnosed Type 2 diabetes mellitus patients with glycemic markers HbA1C>8.5, FBS>160mg/dl, PPBS> 260mg/dl.
2. Patients suffering with any other co-existing medical illness.
3. Patients not willing to give written informed consent.
4. Women who were pregnant or breastfeeding.
5. Patients with serum creatinine level > 1.2 mg/dl.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To compare the efficacy of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus.
2. To compare the safety of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus.
 		 Baseline and Week 12
 
 
Secondary Outcome  
Outcome  TimePoints 
. To compare the safety of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus.  Week 4 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/05/2021 
Date of Study Completion (India) 04/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Type 2 Diabetes Mellitus is characterized by variable degrees of insulin resistance as well as progressive deterioration in the function of pancreatic β cells resulting in impaired insulin secretion which leads to hyperglycemia and subsequent complications.1 Diabetes Mellitus is the 21st century pandemic, according to the International Diabetes Federation (IDF) statistics, global diabetes prevalence is 424.9 million (8.8% of the world population) with 72.9 million from India. India will be the diabetic capital of the World with a projected 134.3 million individuals with diabetes by 2045.2

 

American Diabetic Association recommends Metformin as first-line therapy for patients with type 2 diabetes mellitus at diagnosis3. Its potent blood glucose lowering efficacy, beneficial effects on body weight and lipid profile, proven safety record, low cost, protective effects on cardiovascular system have secured its place as the favored initial drug.4

 

Metformin is available as Immediate release (IR) and Extended release (XR) formulations. The therapeutic profile of metformin has been established over decades of clinical use, largely using an immediate-release formulation that requires administration two or three times daily. Few studies are of the opinion that Extended release formulation has additional advantage such as once daily administration, good compliance, less side effects. However, it is more expensive than immediate-release metformin. There is no consensus with the available literature regarding the superiority of Extended release formulation in terms of Glycemic efficacy. 5-9

 

Considering all these facts, to further strengthen the existing knowledge the present study is undertaken to evaluate the efficacy and safety of Metformin IR verses Metformin XR in patients with type 2 diabetes mellitus.

 
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