A Phase IIb/III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM)

MERCK SHARP & DOHME PERU S.R.L.,0 sites0 target enrollmentJanuary 5, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: -E118 Non-insulin-dependent diabetes mellitus, with unspecified complications-E669 Obesity, unspecified
Sponsor: MERCK SHARP & DOHME PERU S.R.L.,
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

January 5, 2007

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

MERCK SHARP & DOHME PERU S.R.L.,

•1\. Patient has T2DM.
•2\. Patient has a body mass index (BMI) between 27 kg/m2 and 43 kg/m2\.
•3\. Patient is male or female and ≥ 18 and ≤ 75 years of age on day of signing informed consent.
•4\. Patient has been one of the following: a) Newly diagnosed. b) On a stable dose of metformin for at least 12 weeks.
•5\) Patient has an HbA1c ≥ 7\.0% and ≤ 10%.
•6\) Patient is highly unlikely to conceive as indicated by at Least one yes answer to the following questions: a) Patient is male. b) Patient is a surgically sterilized female. c) Patient is a postmenopausal female. d) Patient is of reproductive potential and agrees to remain abstinent or use 2 acceptable methods of birth control throughout the study starting with Visit 1 and for 28 days after the last dose of study drug.
•7\. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate in the study by giving written informed consent.
•8\. Patient is able to read, understand, and complete study questionnaires and diaries.
•9\. Patient is at least 75% compliant with study drug during the single\-blind placebo run\-in.
•10\. Patient is compliant with diet, exercise and other run\-in treatments during the run\-in.

•1\. Patient has a history of type 1 diabetes mellitus.
•2\. Patient is not weight stable.
•3\. Patient intends to be involved in weight loss intervention outside that prescribed by the study.
•4\. Patient has a history of substance abuse within the past 5 years.
•5\. Patient has smoked cigarettes or used nicotine\-containing products within 6 months prior to study initiation, or plans to use such a product over the course of the study.
•6\. Patient has a history or presence of a major psychiatric disorder.
•7\. Patient currently has significant cardiovascular disease.
•8\. Patient has a Visit 1 systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg.
•9\. Patient has a recent diagnosis/episode/recurrence of stroke, TIA or neurological disorder.
•10\. Patient has a history of seizures or is at high risk of developing seizures.