A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00411554
First received: December 13, 2006
Last updated: February 21, 2014
Last verified: February 2014

December 13, 2006
February 21, 2014
January 2007
August 2007   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
  • Hba1c
  • safety and tolerability
Complete list of historical versions of study NCT00411554 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.
  • Change From Baseline in 2 Hour Postprandial Glucose at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.
Plasma glucose
Not Provided
Not Provided
 
A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
Sitagliptin (MK0431) Phase III Double-blind Comparative Study - Type 2 Diabetes Mellitus -

The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
  • Drug: sitagliptin phosphate
    sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
    Other Name: MK0431
  • Drug: Comparator: voglibose
    voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
    Other Name: voglibose
  • Experimental: Sitagliptin 50 mg QD
    sitagliptin 50 mg orally once daily (QD=once daily)
    Intervention: Drug: sitagliptin phosphate
  • Active Comparator: Voglibose 0.2 mg TID
    voglibose 0.2 mg orally three times daily (TID= three times daily)
    Intervention: Drug: Comparator: voglibose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
319
August 2007
August 2007   (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 and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00411554
0431-054, 2006_051
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

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