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

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) Followed by a 1-Year Extension

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430742

Enrollment

600

Registered

2007-02-02

Start date

2006-11-30

Completion date

2008-11-30

Last updated

2015-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus

Brief summary

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.

Interventions

DRUGTaranabant

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

DRUGComparator: Placebo

Placebo capsule once daily. Treatment for 52 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Body weight at 36 weeks, HbA1c at 36 weeks	36 weeks

Secondary

Measure	Time frame
Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks	24 and 52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026