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

A Phase II, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Two-staged, Fixed Design Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Overweight/Obese Patients of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin, Sulphonylurea, or Both.

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.

It is a phase II, prospective, randomized, double-blind, placebo-controlled, dose-ranging, multi-centre, two-staged, fixed-design study of P2202 in patients of type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or sulfonylurea or both. This study will consist of accrual in Stage I (n=56/arm, which is 70% of the total sample size required), followed by an interim analysis on completion of the treatment period, to aid further decisions on accrual and dose selection in Stage II of the study, and completion of Stage I.

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)