A Observational Study to Understand Usage and Effectiveness of Teneligliptin in Indian Patients with Type 2 Diabetes Mellitus

Recruiting

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: CTRI/2018/08/015457
• Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary

A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and EFFect of Teneligliptin as Monotherapy OR Add On Treatment in Indian Type 2 Diabetes Patients on other Antidiabetic Drugs (AFFORD Study) to be conducted across India. A total of 1500 patients are planned from 15 sites across India. The primary objective of the study is to assess the change in HbA1c levels from baseline to week 12 in Indian type 2 diabetes mellitus patients.

The secondary end point includes assessment of change in FBG, PPBG levels and body weight from baseline to week 12. Also to understand usage pattern of teneligliptin as monotherapy or add-on with other oral antidiabetic drugs. It also includes assessment of rate of adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-12
• Last Update Posted: 2018-10-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patient willing to provide informed consent 2.
• Female or male patient aged 18 years or above 3.
• Treatment naïve adult patients or adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs: a.
• HbA1C greater than 6.5% b.
• FBG greter than or equal to 140 mg/dL 4.
• Requirement for teneligliptin as a monotherapy or add-on 5.
• Patients must provide written consent to use personal and/or health data prior to the entry into the study.

Exclusion Criteria

• Patients with Type 1 diabetes mellitus 2.
• Patient on DPP 4 inhibitor other than teneligliptin and GLP 1 analogue therapy 3.
• Any medical condition of the patient which in opinion of Investigator would interfere with safe completion of the study 4.
• Pregnant and lactating woman 5.
• Women of child bearing potential not ready to use an effective barrier contraceptive method during the study 6.
• Patients participating in any other clinical trials.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the change in HbA1c levels from baseline to week 12 in Indian Type 2 diabetes mellitus patients	Visit 1 at baseline | Visit 2 at week 12

Secondary Outcome Measures

Name	Time	Method
1. To assess the change in FBG and PPBG levels from baseline to week 12	2. To understand usage pattern of teneligliptin as monotherapy or add-on with other OADs

Trial Locations

Locations (7)

APOLLO SUGAR CLINICS; 🇮🇳 Mumbai, MAHARASHTRA, India

Dia Care; 🇮🇳 Ahmadabad, GUJARAT, India

DR KOVILS DIABETES CARE CENTRE; 🇮🇳 Mumbai, MAHARASHTRA, India

Jindal Diabetes and Hormone Centre; 🇮🇳 Bhopal, MADHYA PRADESH, India

S.V.S.DIABETES RESEARCH & EDUCATION CENTRE; 🇮🇳 Kolkata, WEST BENGAL, India

SANKET HEALTH CARE AND DIABETIC SERVICES; 🇮🇳 Bangalore, KARNATAKA, India

Vijayratna Diabetes Diagnosis & Treatment Centre; 🇮🇳 Ahmadabad, GUJARAT, India

APOLLO SUGAR CLINICS

🇮🇳Mumbai, MAHARASHTRA, India

Dr Sanjiv Shah

Principal investigator

9820948618

diabetesaction@gmail.com