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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

August 21, 2012
August 2, 2013
April 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01674348 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Drug: Placebo
    Placebo
    Other Name: Placebo
  • 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

    Intervention: Drug: 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

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
July 2013
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01674348
P2202/47/10
Yes
Piramal Enterprises Limited
Piramal Enterprises Limited
Not Provided
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
Piramal Enterprises Limited
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP