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NCT00371007 Clinical Trial

MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)

Type 2 Diabetes Mellitus Clinical Trial

Official title:
MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00371007
Other study ID # 0431-043
Secondary ID 2006_028
Status Completed
Phase Phase 2
First received August 31, 2006
Last updated March 31, 2017
Start date June 1, 2004
Est. completion date April 25, 2005

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

Clinical Trial Summary

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date April 25, 2005
Est. primary completion date April 25, 2005
Accepts healthy volunteers No
Gender All
Age group 20 Years to 69 Years
Eligibility Inclusion Criteria:

- Patients have type 2 diabetes mellitus

- On diet/exercise therapy

Exclusion Criteria:

- Patients have type 1 diabetes mellitus

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks

• Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Nonaka K, Kakikawa T, Sato A, Okuyama K, Fujimoto G, Kato N, Suzuki H, Hirayama Y, Ahmed T, Davies MJ, Stein PP. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Feb;79(2):291-8. Epub 2007 Oct 22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c, safety and tolerability
Secondary Plasma glucose
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