FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039090 [Registered on: 03/01/2022] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of combination of vildagliptin with metformin and glimepiride with metformin in type2 diabetic patients 
Scientific Title of Study   To compare the effect of vildagliptin with metformin versus glimepiride with metformin on inflammatory markers and glycaemic control in type2 diabetes mellitus patients  
Trial Acronym  VilMeGliMeD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Navreet Kaur 
Designation  Post Graduate  
Affiliation  Guru Gobind Singh Medical college and hospital  
Address  Pharmacology department Guru Gobind Singh Medical college and hospital
Sadiq road,Faridkot
Faridkot
PUNJAB
151203
India 
Phone  7696108117  
Fax    
Email  drnavreetkaur1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajkumar 
Designation  Professor  
Affiliation  Guru Gobind Singh medical college and hospital  
Address  Head of department Pharmacology
Sadiq road, Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9646599057  
Fax    
Email  anurajkumar76@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajkumar 
Designation  Professor 
Affiliation  Guru Gobind Singh medical college and hospital  
Address  Head of department pharmacology
Sadiq road,Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9646599057  
Fax    
Email  anurajkumar76@gmail.com  
 
Source of Monetary or Material Support  
Guru Gobind Singh Medical College and Hospital 
 
Primary Sponsor  
Name  Navreet Kaur 
Address  Department of pharmacology,Guru gobind singh medical college and hopsital,Sadiq road,Faridkot 
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 raj kumar  Guru gobind singh hospital  Department of medicine-Unit I, Guru gobind singh medical college, Sadiq road
Faridkot
PUNJAB 
9646599057

anurajkumar76@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethical committee,GGSMCH,Faridkot  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 
Comparator Agent  Glimiperide with Metformin  Tablet glimiperide (1 to 6mg/per day) with tablet metformin (500 to 2000/per day) for 12 weeks. Initially, Tablet glimepirde 1mg with tablet metformin 500mg, once a day with first meal, shall be given to the patient. Further dose and frequency will be titrated according to glycaemic control. Dose range of tablet glimepirde - 1 to 6 mg per day and tablet metformin – 500 to 2000 mg per day. 
Intervention  Vildagliptin with Metformin   Tablet Vildagliptin (50 to 100mg/per day) with tablet Metformin ( 500 to 2000mg/per day) for12 weeks Initially, Tablet vildagliptin 50 mg with tablet metformin 500mg, once a day with first meal, shall be given to the patient. Further dose and frequency will be titrated according to glycaemic control. Dose range of tablet vildagliptin - 50 to 100 mg per day and tablet metformin – 500 to 2000 mg per day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients above 18 years old age, of either sex with type 2 diabetes mellitus
Newly diagnosed type 2 diabetes mellitus patient with HBA1C>8% 
 
ExclusionCriteria 
Details  Other types of diabetes
patients with inflammatory disease (inflammatory bowel disease, lupus, arthritis), hepatic or renal impairment, malignancy, thrombosis and conditions other than type 2 diabetes mellitus
Who are on steroids, anti-inflammatory and immunomodulatory drugs  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to assess the effect of combination therapy on the glycemic level and inflammatory markers   FBS/RBS at 0,2,4,8,10,12 weeks while HBA1C and inflammatory markers(IL6, hCRP and ESR) at 0 and 12 weeks,
Other test LFT and RFT 0,2,4,8,10,12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the adverse events  during and after study period 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/01/2022 
Date of Study Completion (India) 30/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Type 2 diabetes mellitus is a chronic metabolic disorder, which is often associated with long-term microvascular and macrovascular complications. Most of the patients show insulin resistance, common factors linked with insulin resistance are beta-cell dysfunction, tissue lipid accumulation, oxidative stress, endoplasmic reticulum stress(ER-stress) in beta-cells. Above stress, factors overlap with each other and provoke inflammation in beta-cells of pancreatic islets. The purpose of the study is to assess the effect of antidiabetic agents on inflammatory markers like IL-6, hs-CRP, and ESR.

The primary aim of this study is to compare the effect of vildagliptin with metformin and glimepiride with metformin on inflammatory markers in diabetic patients. And the secondary aim is to assess the glycaemic levels and adverse events.

Total 80 diabetic subjects was enrolled from the department of medicine, GGSMCH, Faridkot by using a non-probability convenient sampling technique. Written consent of each subject was taken prior to the enrolment. Study drugs was allocated by using a computerized generating random number table in Group I and group II. Group I was  allocated vildagliptin with metformin, while group II with Glimepiride with metformin. The doses of study drugs was titrated according to the patient’s blood glucose level by the treating physician. Assessment of the subjects was done at 0, 2,4,8,10,12 weeks for FBS, RFT, LFT, etc. while HBA1c, IL6, and hsCRP will be assessed at 0 and 12 weeks.

Type 2 diabetes mellitus patients with age above 18 years, of either sex with HBA1C>8% was included in this study, while patients with inflammatory disease (i.e., inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis), hepatic and renal impairment, malignancy and those who are on steroids, anti-inflammatory or immunomodulatory drugs will be excluded from this study.  

The outcome of this study was, that both the Group I (Vildagliptin-Metformin) and Group II (Glimepiride-Metformin) showed reductions in HbA1c and FBS. No statistically significant difference in glycemic levels was observed between the two groups at the end of the 12-week study period.

Significant reductions in inflammatory markers, including ESR, hs-CRP and IL-6, were observed in both groups. Addition of Vildagliptin to Metformin for 12 weeks significantly reduced hs-CRP and ESR levels compared to the Glimepiride-Metformin treated group [p<0.001].

 

 
Close