NCT00430742

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2006

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

February 1, 2007

Last Update Submit

February 12, 2015

Conditions

Obesity Type 2 Diabetes MellitusType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Body weight at 36 weeks, HbA1c at 36 weeks

    36 weeks

Secondary Outcomes (1)

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

    24 and 52 weeks

Study Arms (4)

1

EXPERIMENTAL

Arm 1: MK0364 0.5 mg capsule once daily

Drug: Taranabant

2

EXPERIMENTAL

Arm 2: MK0364 1 mg capsule once daily

Drug: Taranabant

3

EXPERIMENTAL

Arm 3: MK0364 2 mg capsule once daily

Drug: Taranabant

4

PLACEBO COMPARATOR

Arm 4: Pbo capsule once daily

Drug: Comparator: Placebo

Interventions

TaranabantDRUG

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

123
Comparator: PlaceboDRUG

Placebo capsule once daily. Treatment for 52 weeks.

4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kipnes MS, Hollander P, Fujioka K, Gantz I, Seck T, Erondu N, Shentu Y, Lu K, Suryawanshi S, Chou M, Johnson-Levonas AO, Heymsfield SB, Shapiro D, Kaufman KD, Amatruda JM. A one-year study to assess the safety and efficacy of the CB1R inverse agonist taranabant in overweight and obese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Jun;12(6):517-31. doi: 10.1111/j.1463-1326.2009.01188.x.

    PMID: 20518807RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

November 1, 2006

Primary Completion

January 1, 2008

Study Completion

November 1, 2008

Last Updated

February 13, 2015

Record last verified: 2015-02