A study to compare the usage and safety of Teneligliptin versus Glimepiride in diabetic patients being treated with Metformin

Not yet recruiting

• Conditions: Type II Diabetes Mellitus

• Registration Number: CTRI/2017/08/009262
• Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary

A Non-Interventional, Multicenter, Prospective,Observational Comparative, Study to Understand Usage, Safety and Effect ofTENeligliptin Vs. GLImepiride as an Add-on to METformin Treatment in IndianType 2 Diabetes Patients (**TENGLIMET Study**). A total 500 patients are plannedfrom 10 sites across India. The primary objectives of the study are to assessthe occurrence of hypoglycemic episodes, change in HbA1c and body weightbetween teneligliptin and glimepiride groups. The secondary objectives are toassess change in Fasting Blood Glucose (FBG), Postprandial Blood Glucose(PPBG) from baseline to week 24. Also, to understand the study drug usagepattern and occurrence of adverse events.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-03-08
• Study Start: 2017-07-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.Patient willing to provide informed consent 2.Female or male patient aged 18 years or above 3.Adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and metformin: –HbA1C: 7 to 9% –FBG: ≥140 mg/dL 4.Physician prescribes teneligliptin or glimepiride as an add-on to metformin therapy 5.Patients must provide written consent to use personal and/or health data prior to the entry into the study.

Exclusion Criteria

1.Patients with Type 1 diabetes mellitus 2.Patient on antidiabetic therapy other than glimepiride, teneligliptin and metformin 3.Contraindications for teneligliptin and glimepiride as per respective approved prescribing information 4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study 5.Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the occurrence of hypoglycemic episodes between two groups	Baseline, Week 12 and Week 24
2. To assess the change in HbA1c levels from baseline to week 24	Baseline, Week 12 and Week 24
3. To assess the effect of both the treatments on body weight	Baseline, Week 12 and Week 24

Secondary Outcome Measures

Name	Time	Method
1. To assess the change in FBG and PPBG levels from baseline to week 24	2. To understand the utilization pattern of teneligliptin

Trial Locations

Locations (1)

Life Care Clinic and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Life Care Clinic and Research Centre

🇮🇳Bangalore, KARNATAKA, India

Dr L Sreenivasa Murthy

Principal investigator

080-23631055

drlsm@lcrc.in