A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

It is a phase II, randomized, double-blind, placebo-controlled study of P2202 in patients of type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or sulfonylurea or both.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Piramal Enterprises Limited

Criteria

Inclusion Criteria:

• Subjects who understand and are willing to give informed consent to participate in the trial.

• Adult male and female subjects between 18 years to 65 years of age with a BMI ≥ 27 kg/m2 ≤ 40 kg/m2, inclusively.

• Subjects with established type 2 diabetes mellitus of at least 3 months duration at the time of screening.

• Subjects with an inadequate glycemic control defined by an HbA1c level of ≥ 7.5% and ≥10% at screening.

• Subjects who are on a stable dose of:

• Metformin (up to 2.55 gm/day or maximum tolerated dose of at least 1 gm/day) and/or

• Sulfonylurea (glimepiride ≤ 4 mg/day, gliclazide ≤ 160 mg, glibenclamide or glyburide ≤ 10 mg and glipizide ≤ 10 mg), for ≤ 2 months prior to the screening visit.

• Subjects with fasting plasma glucose of ≤14.4 mmol/L (260 mg/dL) and at least 5.5 mmol/L or 100 mg/dL.

Exclusion Criteria:

• Subjects who have type 1 diabetes mellitus, maturity-onset diabetes of the young or any rare form of diabetes. Subjects with hyperglycemia due to secondary causes.

• Subjects who have had more than 4 episodes of severe hypoglycemia in the 6 months prior to screening.

• Subjects with a history of acute diabetic complications

• Subjects who have been treated with insulin (except for use of insulin for short term management of acute conditions), thiazolidinediones, dual proliferator activated receptors agonists, glucagon-like peptide analogues, dipeptidyl peptidase inhibitors or 11bHSD-1 inhibitors in any form, in the 3 months prior to screening.

• Subjects who are receiving systemic glucocorticoids (≥14 days)