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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01674348
• Other study ID #: P2202/47/10
• Status: Terminated
• Phase: Phase 2
• First received: August 21, 2012
• Last updated: August 2, 2013
• Start date: April 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Piramal Enterprises Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• P2202
Novel oral drug with potent and selective 11 beta-hydroxysteroid dehydrogenase type 1 (11b-HSD1) inhibitory properties, being developed for the management of type 2 diabetes mellitus
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	LMC Endocrinolgy Centres Ltd	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Enterprises Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic profile (Cmax, Tmax and AUC)	PK parameters derived will be maximum plasma concentration (Cmax), time at which Cmax is reached (Tmax), area under the plasma concentration curve calculated up to 24 hours (AUC 0-24h), area under the curve extrapolated to infinity (AUC 0-inf), elimination rate constant (Kel), volume of distribution (Vz), terminal elimination half life (t1/2) and protein binding.	Pre dose at Day 1 Week 1 till Week 12	No
Primary	Change in HbA1c from baseline	The change in HbA1c from baseline till end of 12 weeks in patients of type 2 diabetes mellitus, in the P2202 arms as compared to placebo.	From baseline till end of 12 weeks	No
Secondary	Number of subjects with adverse events	Safety assessment will be done by eliciting information regarding AEs including evaluation of hypoglycemic events, physical examination, vital signs assessment, 12-lead ECGs, clinical laboratory tests, markers of HPA axis function, plasma ACTH and free testosterone, plasma rennin and serum aldosterone and self-monitoring of blood glucose profiles.	From screening to 3 weeks (± 1 week) after the last visit at the end of Week 12 or early exit visit	Yes