Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus
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.
Interventions
DRUGP2202
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
DRUGPlacebo
Placebo
Sponsors
Piramal Enterprises Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from baseline | From baseline till end of 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile (Cmax, Tmax and AUC) | Pre dose at Day 1 Week 1 till Week 12 | 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. |
Countries
Canada
Outcome results
None listed