A Phase II, 12-Week Randomised, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Effect On Glycemic Control of P1736-05 in Subjects with Type 2 Diabetes Mellitus - P1736-05 POC study

Piramal Life Sciences Limited0 sites40 target enrollmentNovember 3, 2009

ConditionsDiabetes mellitus, type 2 (Blood Glucose Lowering Effect)/

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes mellitus, type 2 (Blood Glucose Lowering Effect)/
Sponsor: Piramal Life Sciences Limited
Enrollment: 40
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 3, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Piramal Life Sciences Limited

Eligibility Criteria

Inclusion Criteria

•1\. Age: 18\- 70 yrs, inclusive
•2\. BMI: 25 \- 40 kg/m2, inclusive
•3\. HbA1c: at screening between 6\.2 and 9\.5 % for subjects on antidiabetic medication and between 7 and 10% for subjects on diet and exercise
•4\. FPG: at randomization \=12\.5 mmol/l
•5\. Fasting C\-peptide: at screening \=0\.16nmol/L (\>0\.5ng/ml)
•6\. For men willingness to use adequate contraception from screening until 3 months after the follow\-up visit
•7\. For females: negative pregnancy test at screening and each admission, or of no childbearing potential (females) (a prerequisite for female subjects of childbearing potential is adequate contraception during the study and until 3 months after the follow\-up visit)
•Postmenopausal females: postmenopausal status is usually based on history of amenorrhoea duration (no menstrual period for 24 consecutive months)
•8\. Has an established clinical diagnosis of stable type 2 diabetes mellitus for at least 3 months prior to the screening period; (Type 2 Diabetes Mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization (WHO) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus \[American Diabetes Association, 2006]
•9\. Currently on oral hypoglycemic drugs with metformin or sulfonyl urea either as monotherapy or combination therapy or Drug naive (Defined as subjects not received any pharmacological treatment for at least 12 weeks before screening and no anti diabetic agents for \> 3 consecutive months any time in the past).

Exclusion Criteria

•1\. MODY (Mature Onset Diabetes of the Young), insulin dependent type 2 diabetes mellitus, or other unusual or rare forms of diabetes mellitus
•2\. Has had \>4 episodes of severe hypoglycemia that required the assistance of another person within the past 6 months (brittle diabetes)
•3\. Type 2 Diabetes of more than 15 years duration prior to screening.
•4\. Has a history of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar nonketotic coma
•5\. Has used insulin previously within past 3 months prior to screening
•6\. Has used GLP\-1 analog (for example, exenatide) within 6 months prior to screening
•7\. Has used Thiazolidinediones or DPP4 inhibitors within 6 months prior to screening.
•8\. Has received any investigational drug within 60 days prior to study entry
•9\. Has a history of hypersensitivity or allergies to similar class of drug as the study drug, unless approved by the Investigator
•10\. Has a clinically significant history of substance or alcohol abuse within the past year or a current diagnosis of substance or alcohol abuse