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CTRI Number  CTRI/2019/06/019926 [Registered on: 28/06/2019] Trial Registered Prospectively
Last Modified On: 10/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF METFORMIN AND GLIMEPIRIDE IN PATIENTS OF COEXISTING TYPE 2 DIABETES MELLITUS AND NON ALCOHOLIC FATTY LIVER DISEASE 
Scientific Title of Study   COMPARATIVE EVALUATION OF EFFICACY AND SAFETY OF METFORMIN AND GLIMEPIRIDE WITH CONCOMITANT ROSUVASTATIN IN PATIENTS OF NON ALCOHOLIC FATTY LIVER DISEASE WITH COEXISTENT TYPE 2 DIABETES MELLITUS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prabhsimran Kaur 
Designation  Junior Resident 
Affiliation  Government Medical College, Amritsar 
Address  Department of Pharmacology, GMC, Circular Road, Amritsar 143001

Amritsar
PUNJAB
143001
India 
Phone  9888269281  
Fax    
Email  prabh93simran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gurpreet Kaur Randhawa 
Designation  Professor 
Affiliation  Government Medical College , Amritsar 
Address  Department of Pharmacology, GMC, Circular Road, Amritsar 143001

Amritsar
PUNJAB
143001
India 
Phone  9501009338  
Fax    
Email  kullar.g@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prabhsimran Kaur 
Designation  Junior Resident 
Affiliation  Government Medical College, Amritsar 
Address  Department of Pharmacology, GMC, Circular Road, Amritsar 143001

Amritsar
PUNJAB
143001
India 
Phone  9888269281  
Fax    
Email  prabh93simran@gmail.com  
 
Source of Monetary or Material Support  
Dr Prabhsimran Kaur, Department of Pharmacology, Government Medical College, Amritsar  
 
Primary Sponsor  
Name  nil 
Address  - 
Type of Sponsor  Other [Self] 
 
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 Prabhsimran Kaur  Guru Nanak Dev Hospital, Amritsar  Department of Medicine, Unit 6,Room no. 15, Guru Nanak Dev Hospital, Amritsar, Punjab
Amritsar
PUNJAB 		 9888269281

prabh93simran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Medical College, Amritsar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glimepiride and Rosuvastatin  Glimepiride (3mg BD) and Rosuvastatin (10mg OD) for a duration of 3 months in patients of NAFLD concomitant with newly diagnosed Type 2 Diabetes Mellitus 
Intervention  Metformin and Rosuvastatin   Metformin (1 gm BD) and Rosuvastatin (10 mg OD) for a duration of 3 months in patients of NAFLD concomitant with newly diagnosed Type 2 Diabetes Mellitus  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  o NAFLD diagnosed by suggestive imaging findings (ultrasound) with
abnormal aminotransferase levels. AST 50-150 U/L (1 to 3 times the
upper limit of normal).
o Concomitant with newly diagnosed T2DM.
o Subjects between age group 20 – 60 years of either sex 
 
ExclusionCriteria 
Details  1. Hypersensitivity to metformin, glimepiride and rosuvastatin.
2. Patients with age group < 20 years and > 60 years.
3. Patients with Type 1 Diabetes and Type 2 diabetes with end stage
complications and diabetic ketoacidosis.
4. Pregnancy and lactation.
5. Patients with hypotensive states, thyroid disorders, adrenal insufficiency,
heart failure, respiratory disorders tuberculosis, hepatobiliary disease,
chronic renal disease.
6. Patients with hepatitis B & C and significantly deranged enzymes (ALT>
3 times normal values)
7. Patients with ascites, inflammatory bowel disease, malignancies, G6PD
deficiency.
8. Patients on drugs causing hepatic steatosis.
9. Chronic drug or alcohol abuse (daily intake > 20g (2.5 units) in females
and 30g (3.5 units) in males
10. Patients with comorbidities like microvascular complications, recent (<1
year) Myocardial infarction, acute coronary syndrome, stroke, osmotic
symptoms, history of ketosis, weight loss of >3 kg in preceding 3 months.
11. Patients on drugs causing fatty liver changes like – amiodarone,
methotrexate, tamoxifen, antiretroviral drugs, tetracyclines,
acetaminophen & corticosteroids.
12. Patients on drugs like cimetidine, gemfibrozil, cyclosporine, digoxin,
warfarin, beta blockers, calcium channel blockers, macrolide antibiotics,
azole antifungals, cholestyramine, diazoxide, oestrogens, hydantoin,
isoniazid, nicotinic acid, phenothiazines, rifampin, thiazide diuretics,
urinary alkalinizers, furosemide.
13. Patients with megaloblastic anaemia, myopathy
14. Any trauma, surgery.
15. Patients refusing to give informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect on histological features of ultrasound liver in patients at the end of treatment
 		 0 and 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on Aminotransferase levels at the end of the treatment  0,30,60,90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Non alcoholic fatty liver disease (NAFLD) is a rising health concern and is strongly associated with Type 2 Diabetes mellitus (T2DM) with insulin resistance being the pivotal feature between the two. The prevalence of NAFLD is 59.67% in T2DM. NAFLD includes pathological ectopic fat deposition along with low grade chronic inflammatory state in the liver cells. No specific therapy is yet approved for coexisting NAFLD & T2DM and fewer studies have been done to assess the efficacy and safety of metformin and glimepiride in it. The present study aims to compare the efficacy and safety of metformin and glimepiride with concomitant rosuvastatin in patients of NAFLD coexistent with T2DM. It will be interventional, randomized, prospective, parallel, open-label and intention to treat study of 12 weeks. It will comprise of 60 patients of either sex (20- 60 years) from Department of Medicine, Guru Nanak Dev Hospital, attached to Government Medical College, Amritsar. Patients will be randomly divided into two groups- A & B of thirty each. Group A will be prescribed metformin 1 gm BD and rosuvastatin 10 mg OD. Group B will be prescribed glimepiride 3 mg BD and rosuvastatin 10 mg OD. Follow up will be done every 15 days for 12 weeks and will undergo assessment of anthropometric parameters, liver function tests, renal function tests, lipid profile, fasting blood sugar, HbA1c, insulin resistance and ultrasound of liver. Data will be tabulated and analyzed statistically.  
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