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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00430742
• Other study ID #: 0364-011
• Secondary ID: 2006_021
• Status: Terminated
• Phase: Phase 3
• First received: February 1, 2007
• Last updated: February 12, 2015
• Start date: November 2006
• Est. completion date: November 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity Type 2 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Taranabant
Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
• Comparator: Placebo
Placebo capsule once daily. Treatment for 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 tara — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight at 36 weeks, HbA1c at 36 weeks		36 weeks	No
Secondary	Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks		24 and 52 weeks	No