Safety and Efficacy Study of Fixed Dose Combination of Three Antidiabetic Drugs in Comparison to Two Antidiabetic Drugs in Patients with Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: CTRI/2016/11/007439
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 301

Inclusion Criteria

Subjects must meet all of the following criteria to be considered for enrollment in the study:

1.Male or female patients aged between 18 to 65 years

2.Patients diagnosed with type 2 diabetes

3.Patients having HbA1c ratio of > 7.5 and < 9

4.Patients having BMI of > 23 and < 30 kg/m2

5.Patients having Postprandial Blood Glucose (2 hours post- meal) concentration more than 200 mg/dl

6.Patients currently on treatment with stable dose of combination of Glibenclamide 5 mg and Metformin 500 mg twice daily for at least 12 weeks before screening.

7.Subject or his legally accepted representative is willing to give informed consent

Exclusion Criteria

Subjects meeting any of the following criteria must be excluded from enrollment in the study:

1.The patients with the history of serious hypoglycemia shall be excluded.

2.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control

3.Presence of any clinically relevant disease (e.g. Type I diabetes mellitus, severe cardiovascular disease, significant renal or hepatic impairment, diabetic coma or pre coma, acute or chronic metabolic acidosis including diabetic ketoacidosis and lactic acidosis, severe infection, serious trauma, congestive heart failure that requires treatment etc.)

4.Patients having Fasting Blood Glucose concentration more than 270 mg/dl

5.Patients received long term insulin therapy (<= 3 days of treatment is allowed)

6.Patients who fall into New York Heart Association (NYHA) class III or IV

7.Patients receiving Bosentan

8.Surgical or medical condition that, in the judgment of the Investigator, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used

9.Current or recent substance abuse, including alcohol

10.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests

11.Participation in any experimental drug study within 60 days before screening

12.Subjects having intolerance, hypersensitivity or any other contraindication to any of the study products

13.Subjects judged unfit for this study by investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified