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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Type 2 Diabetes Mellitus; Obesity Type 2 Diabetes Mellitus

Treatments: Drug: Taranabant; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430742

0364-011

2006_021

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Arm 1: MK0364 0.5 mg capsule once daily

Treatment:

Drug: Taranabant

2

Experimental group

Description:

Arm 2: MK0364 1 mg capsule once daily

Treatment:

Drug: Taranabant

3

Experimental group

Description:

Arm 3: MK0364 2 mg capsule once daily

Treatment:

Drug: Taranabant

4

Placebo Comparator group

Description:

Arm 4: Pbo capsule once daily

Treatment:

Drug: Comparator: Placebo