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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00371007
First received: August 31, 2006
Last updated: December 2, 2014
Last verified: December 2014

August 31, 2006
December 2, 2014
June 2004
April 2005   (final data collection date for primary outcome measure)
HbA1c, safety and tolerability
Same as current
Complete list of historical versions of study NCT00371007 on ClinicalTrials.gov Archive Site
Plasma glucose
Same as current
Not Provided
Not Provided
 
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)
MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks
  • Drug: Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
April 2005
April 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients have type 2 diabetes mellitus
  • On diet/exercise therapy

Exclusion Criteria:

  • Patients have type 1 diabetes mellitus
Both
20 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00371007
0431-043, 2006_028
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP