Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)

Diabetes Mellitus Type 2 Clinical Trial

Official title:

An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543959
• Other study ID #: 0533-005
• Secondary ID: MK0533-0052007_5
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2007
• Last updated: June 22, 2015
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: June 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 study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 346
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels

• Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened

Exclusion Criteria:

• Patients taking any medicines that affect body fluid level such as a diuretic or water pill

• Patients taking niacin or other certain medications

• Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders

• Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study

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
• Diabetes Mellitus, Type 2

Intervention

Drug:
• MK0533
Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.
• Comparator: Placebo (unspecified)
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
• Comparator: pioglitazone
pioglitazone 45mg. Study period is a total of 24 wks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fluid gain from baseline after 12 weeks		12 weeks	No
Secondary	Fasting plasma glucose after 12 weeks		12 weeks	No