Back to resultsA Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
P2202
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus
Eligibility 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)
Sites / Locations
- LMC Endocrinolgy Centres Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
P2202
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01674348
First Posted
August 21, 2012
Last Updated
August 2, 2013
Sponsor
Piramal Enterprises Limited
1. Study Identification
Unique Protocol Identification Number
NCT01674348
Brief Title
A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to non-recruitment, the study is being halted. There are no major safety or tolerability concerns in the study conducted so far.
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Piramal Enterprises Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P2202
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
P2202
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline
Description
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.
Time Frame
From baseline till end of 12 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Description
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.
Time Frame
From screening to 3 weeks (± 1 week) after the last visit at the end of Week 12 or early exit visit
Other Pre-specified Outcome Measures:
Title
Pharmacokinetic profile (Cmax, Tmax and AUC)
Description
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.
Time Frame
Pre dose at Day 1 Week 1 till Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ronnie Aronson, M.D.
Organizational Affiliation
Health Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Robert Petrella, M.D.
Organizational Affiliation
Health Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Naresh Aggarwal, M.D.
Organizational Affiliation
Health Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
LMC Endocrinolgy Centres Ltd
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes
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