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

This study has been terminated.
(Due to non-recruitment, the study is being halted. There are no major safety or tolerability concerns in the study conducted so far.)
Sponsor:
Information provided by (Responsible Party):
Piramal Enterprises Limited
ClinicalTrials.gov Identifier:
NCT01674348
First received: August 21, 2012
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: P2202
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Piramal Enterprises Limited:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: From baseline till end of 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: From screening to 3 weeks (± 1 week) after the last visit at the end of Week 12 or early exit visit ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Pharmacokinetic profile (Cmax, Tmax and AUC) [ Time Frame: Pre dose at Day 1 Week 1 till Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: April 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: P2202

Two treatment arms in Stage I- P2202 (1000 mg) and placebo

Four treatment arms in stage II- P2202 (suggested dose levels 750 mg, 500 mg or 250 mg) or placebo

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
Other Name: P2202
Placebo Comparator: Placebo

Two treatment arms in Stage I- P2202 (1000 mg) and placebo

Four treatment arms in stage II- P2202 (suggested dose levels 750 mg, 500 mg or 250 mg) or placebo

Drug: Placebo
Placebo
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674348

Locations
Canada, Ontario
LMC Endocrinolgy Centres Ltd
Toronto, Ontario, Canada, M4G 3E8
Sponsors and Collaborators
Piramal Enterprises Limited
Investigators
Principal Investigator: Dr. Ronnie Aronson, M.D. Health Canada
Principal Investigator: Dr. Robert Petrella, M.D. Health Canada
Principal Investigator: Dr. Naresh Aggarwal, M.D. Health Canada
  More Information

No publications provided

Responsible Party: Piramal Enterprises Limited
ClinicalTrials.gov Identifier: NCT01674348     History of Changes
Other Study ID Numbers: P2202/47/10
Study First Received: August 21, 2012
Last Updated: August 2, 2013
Health Authority: Canada: Health Canada
India: Drugs Controller General of India

Keywords provided by Piramal Enterprises Limited:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014