A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482079
• Other study ID #: 0431-010
• Secondary ID: 2007_578
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2007
• Last updated: March 24, 2017
• Start date: May 13, 2003
• Est. completion date: June 15, 2006

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: June 15, 2006
• Est. primary completion date: August 25, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 21 to 70, You are a man or non-pregnant woman

Exclusion Criteria:

• Have a history of type I diabetes

• You are on a weight loss program with ongoing weight loss or taking weight loss medications

• You have a history of minor surgery

• You have received investigational drugs within 8 weeks of study start

• You have hepatitis B or C

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks

• Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses the effectiveness of MK0431 compared to placebo		over 12 weeks
Secondary	To test the safety and tolerability of MK0431 in patients with type 2 diabetes