Clinical trial NCT01674348: A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: Piramal Enterprises Limited
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: From baseline till end of 12 weeks
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: From screening to 3 weeks (± 1 week) after the last visit at the end of Week 12 or early exit visit
Other outcomes:
measure: Pharmacokinetic profile (Cmax, Tmax and AUC)
timeFrame: Pre dose at Day 1 Week 1 till Week 12
Locations:
city: Toronto
country: Canada
facility: LMC Endocrinolgy Centres Ltd
state: Ontario
Study officials:
affiliation: Health Canada
name: Dr. Ronnie Aronson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Canada
name: Dr. Robert Petrella, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Canada
name: Dr. Naresh Aggarwal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: