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Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00106704
First received: March 29, 2005
Last updated: November 19, 2010
Last verified: November 2010
History of Changes

March 29, 2005
November 19, 2010
April 2005
January 2007   (final data collection date for primary outcome measure)
Change From Baseline in A1C at Week 24 [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
  • (1)After 24 weeks, reduction in HbA1c;
  • (2) Safety and Tolerability
Complete list of historical versions of study NCT00106704 on ClinicalTrials.gov Archive Site
Change From Baseline in FPG at Week 24 [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
After 24 weeks, greater reduction in glycemic control
 
 
 
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Comparator: Sitagliptin
    sitagliptin 10 mg tablet, once daily for 54 weeks
  • Drug: Comparator: Placebo
    Placebo oral tablet once daily for 24 weeks
  • Drug: Comparator: Pioglitazone
    Pioglitazone 30 mg tablet once daily for 30 weeks
  • Experimental: Sitagliptin
    Sitagliptin 10 mg tablet daily for 54 weeks
    Intervention: Drug: Comparator: Sitagliptin
  • Placebo Comparator: Placebo/ Pioglitazone
    Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
    Interventions:
    • Drug: Comparator: Placebo
    • Drug: Comparator: Pioglitazone
Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. Epub 2007 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
441
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria:

  • Patients with Type 1 Diabetes Mellitus
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00106704
2005_009, MK0431-035
 
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck
 
Study Director: Medical Monitor Merck
Merck
November 2010

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