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Clinical Trial Details

Trial ID: L2421
Source ID: NCT01674348
Associated Drug: P2202
Title: A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: P2202|DRUG: Placebo
Outcome Measures: 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 | 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 | 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
Sponsor/Collaborators: Sponsor: Piramal Enterprises Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-04
Completion Date: 2013-07
Results First Posted:
Last Update Posted: 2013-08-05
Locations: LMC Endocrinolgy Centres Ltd, Toronto, Ontario, M4G 3E8, Canada
URL: https://clinicaltrials.gov/show/NCT01674348