An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)

Phase 3TerminatedNCT00430742

Merck Sharp & Dohme LLC600 enrolled

Overview

A worldwide study with extension in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug for weight loss on body weight.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Obesity Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

TaranabantDRUG

Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.

Comparator: PlaceboDRUG

Placebo capsule once daily. Treatment for 52 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10% Exclusion Criteria: * History of major psychiatric disorder * Blood pressure greater than 160/100 * Use of any antihyperglycemic agent other than metformin * Triglycerides greater then 600 mg/dL

Outcomes

Primary Outcomes

Body weight at 36 weeks, HbA1c at 36 weeks

Time frame: 36 weeks

Secondary Outcomes

Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks

Time frame: 24 and 52 weeks

Data from ClinicalTrials.gov

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