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

NCT01674348 | Terminated Phase 2 DMC

• 1 other identifier: P2202/47/10
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of subjects with adverse events

  From screening to 3 weeks (± 1 week) after the last visit at the end of Week 12 or early exit visit

Other Outcomes (1)

• Pharmacokinetic profile (Cmax, Tmax and AUC)

  Pre dose at Day 1 Week 1 till Week 12

Study Arms (2)

P2202

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

P2202 DRUG

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

P2202

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (1)

LMC Endocrinolgy Centres Ltd

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 28, 2012
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

CA (1)