A clinical trial to study the effect of Fixed Dose Combination of Teneligliptin and Metformin Tablet in the treatment of patients with Type 2 Diabetes Mellitus.

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.

• Registration Number: CTRI/2014/08/004827
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is double-blind, double dummy, randomized, active controlled, two-arm, parallel-group, comparative study. Study will enroll 378 subjects with type 2 diabetes from the different centres in India.    xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in 1:1 ratio to receive either Fixed Dose Combination of Teneligliptin and Metformin or Metformin for 24 weeks. The primary objective of the study is to see the mean change in Glycosylated Haemoglobin (HbA1c) levels at the end of treatment. Secondary objective includes proportion of patients achieving the goal of ≤7.0% HbA1c level, mean change for fasting and postprandial plasma glucose. During the study, there will be 7 study visits for efficacy, safety and tolerability assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-18
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

• Patients age ≥18 and ≤65 years inclusive of either sex willing to give their written informed consent and comply with the protocol requirements.
• Patients with Type 2 Diabetes Mellitus who have been treated with upto 1 gram per day of Metformin monotherapy for at least 3 months prior to screening and having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of >7% to ≤ 9%].

Exclusion Criteria

• Pregnant or lactating women.
• Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
• Patient with Type 1 diabetes mellitus or secondary form of diabetes.
• Patients with known hypersensitivity to any of the components of the formulation.
• Known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis.
• Patients who have a recent history or who are currently known to abuse alcohol or drugs.
• Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, collagen disorders, severe infection etc.
• or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
• Patients receiving treatment with systemic corticosteroids.
• Patients who have participated in any clinical trial in the past 1 month.
• Any other condition that in the opinion of the Investigator that does not justify the patient’s participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change in Glycosylated Haemoglobin (HbA1c) levels	24 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving the goal of HbA1c ≤7% level	24 weeks
Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)	24 weeks

Trial Locations

Locations (56)

Apex Hospital Pvt. Ltd.; 🇮🇳 Jaipur, RAJASTHAN, India

Apollo Gleneagles Hospitals; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Hospitals International Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Aster Aadhar Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

B L Kapoor Super Specialty Hospital; 🇮🇳 Delhi, DELHI, India

Bhatia Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

BJ Government Medical College and Sassoon General Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Deenanath Mangeshkar Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Diabetes Thyroid & Endocrine Centre; 🇮🇳 Jaipur, RAJASTHAN, India

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Apex Hospital Pvt. Ltd.

🇮🇳Jaipur, RAJASTHAN, India

Dr Vipul Khandelwal

Principal investigator

9829193517

dr.vipul@yahoo.co.in