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
|
|
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
|
|
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]. |