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

An Open-Label, Randomized, Active-controlled, Multicentric Study to Assess the Efficacy and Safety of PDM011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/01/003308

Enrollment

150

Registered

2013-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 diabetes mellitus

Interventions

Intervention1: PDM011011 (Bitter melon capsules): Capsule contains 400 mg extract of standardized powder of bitter melon juice. The dose is 1200 mg per day and is administered as 1 capsule before brea

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean change in fasting plasma glucose between active and comparator groupsTimepoint: Baseline and week 15	—

Secondary

Measure	Time frame
Mean change in HbA1c between active and comparator groupsTimepoint: Baseline and week 15	—

Countries

India

Contacts

Public ContactDr Ashish Suthar

Piramal Healthcare Limited

purvi.chawla@piramal.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026