MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00289848
First received: February 7, 2006
Last updated: May 9, 2014
Last verified: May 2014

February 7, 2006
May 9, 2014
April 2006
March 2007   (final data collection date for primary outcome measure)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
(1) After 18 weeks, to assess the effect of treatment with MK0431 compared with placebo on HbA1c; (2) To Assess the safety and tolerability of MK0431.
Complete list of historical versions of study NCT00289848 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
  • Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Change from baseline at Week 18 is defined as Week 18 minus Week 0.
(1) After 18 weeks, to assess the effect of treatment with MK0431 compared with placebo on: (1) Fasting plasma glucose (FPG) and (2) 2-Hour post-prandial glucose, after a standard meal challenge.
Not Provided
Not Provided
 
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: sitagliptin phosphate
    Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
    Other Name: Januvia
  • Drug: Comparator: placebo
    placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
  • Experimental: 1
    sitagliptin 100 mg
    Intervention: Drug: sitagliptin phosphate
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Comparator: placebo
Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. Epub 2008 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Exclusion Criteria :

  • Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00289848
0431-040, MK0431-040, 2005_094
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

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