Study of combination of vildagliptin with metformin and glimepiride with metformin in type2 diabetic patients
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2022/01/039090
- Lead Sponsor
- Navreet Kaur
- Brief Summary
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].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Patients above 18 years old age, of either sex with type 2 diabetes mellitus Newly diagnosed type 2 diabetes mellitus patient with HBA1C>8%.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Assess the adverse events during and after study period
Trial Locations
- Locations (1)
Guru gobind singh hospital
🇮🇳Faridkot, PUNJAB, India
Guru gobind singh hospital🇮🇳Faridkot, PUNJAB, IndiaDr raj kumarPrincipal investigator9646599057anurajkumar76@gmail.com