A trial to study the efficacy and safety of PDM011011 capsules in comparison with metformin in type 2 diabetic patients.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus

• Registration Number: CTRI/2013/01/003308
• Lead Sponsor: Piramal Healthcare Limited

Brief Summary

Diabetes management primarily involves diet and lifestyle modifications followed by treatment with oral agents. Treatment with diet, insulin and oral agents like sulfonylurea, or metformin is known to improve glycemia. The main constituent of PDM011011 is a powder of the natural juice of Karela or bitter melon.  Karela is an edible vegetable item in Indian food and has been known for his blood sugar lowering as well as lipid lowering capabilities.  Several studies and anecdotal evidence show that bitter melon capsules are associated with improved glycemic control, lower post-prandial sugar levels and triglyceride levels, which help in decreasing the risk for coronary heart diseases.

Based on promising response in previous user trials and innovation in the extraction process, PHL proposed a comparative trial to evaluate the efficacy and safety of bitter melon capsule versus metformin, which is the standard of choice in patients of type 2 diabetes mellitus.

This is the first human trial with this product and hence, no prior clinical data is available.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-08
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Type 2 diabetic patients with an HbA1c between 7 to 10% and fasting plasma glucose between 110 mg/dl and 250 mg/dl.

Exclusion Criteria

Patients of type 1 diabetes, secondary diabetes mellitus, pregnany or lactating women, with any other clinically significant abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in fasting plasma glucose between active and comparator groups	Baseline and week 15

Secondary Outcome Measures

Name	Time	Method
Mean change in HbA1c between active and comparator groups	Baseline and week 15

Trial Locations

Locations (9)

Ashirwad Hospital and Medical Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Clinic De Care; 🇮🇳 Thane, MAHARASHTRA, India

Ethika Clinical Research Center; 🇮🇳 Thane, MAHARASHTRA, India

Ira Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Kolkes Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Orange Diabetes Clinical Research Unit; 🇮🇳 Pune, MAHARASHTRA, India

Poona Diabetes Centre; 🇮🇳 Pune, MAHARASHTRA, India

Tongaonkar Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Vikas Govind Pai Clinical Research Foundation; 🇮🇳 Pune, MAHARASHTRA, India

Ashirwad Hospital and Medical Research Centre

🇮🇳Thane, MAHARASHTRA, India

Dr Shrikant V Deshpande

Principal investigator

00919822017445

shrikantvdeshpande@rediffmail.com