A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes
NCT01674348 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2013-08-05
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
Interventions
- 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
- DRUG
-
Placebo
Sponsors & Collaborators
-
Piramal Enterprises Limited
lead INDUSTRY
Principal Investigators
-
Dr. Ronnie Aronson, M.D. · Health Canada
-
Dr. Robert Petrella, M.D. · Health Canada
-
Dr. Naresh Aggarwal, M.D. · Health Canada
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2012-12-31
- Completion
- 2013-07-31
Countries
- Canada
Study Locations
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