A comparative study between Teneligliptin and Glimepiride in Type 2 diabetes mellitus patients

Not Applicable

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/08/035342
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-20
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Type 2 Diabetes patients not controlled by Metformin alone (with HbA1C > 7% )

Age > 20 years and < 60 years

Both male and female genders 

Exclusion Criteria

Type 2 Diabetes patients who are already on any DPP4 inhibitors & Metformin combination therapy or on Insulin or any other incretin based therapy or any hypoglycaemic agents

Patients with any acute inflammatory/ infective condition with CRP > 10 mg/L and any history of acute infection/ inflammation in past 3 months 

Patients with chronic inflammatory conditions, autoimmune diseases, Neoplasia

Patients with serious macrovascular complications such as acute MI, angina or stroke within six months of enrolment

Type 1 Diabetes patients or any other form of diabetes

Pregnant or Breastfeeding females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in hsCRP & plasma insulin levels <br/ ><br>Changes in lipid profile,body weight, BP, Glycemic profile, Cardiovascular-Renal indicesTimepoint: Changes in hsCRP & plasma insulin levels <br/ ><br>Changes in lipid profile,body weight, BP, Glycemic profile, Cardiovascular-Renal indices at baseline and end of treatment - 12 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy,safety,cost,compliance,adherence pattern,treatment satisfaction for TeneligliptinTimepoint: Baseline (0 weeks), End of study (12 weeks)