Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704132
First received: June 23, 2008
Last updated: August 21, 2013
Last verified: August 2013

June 23, 2008
August 21, 2013
February 2007
April 2010   (final data collection date for primary outcome measure)
Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Incremental glucose AUC, safety, and tolerability [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00704132 on ClinicalTrials.gov Archive Site
Not Provided
Beta-Cell function, Incretin response [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059 AM1)
A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus (T2DM)
  • Drug: Comparator: sitagliptin phosphate
    Sitagliptin tablet 100 mg, administered once daily before the morning meal.
  • Drug: Comparator: placebo (unspecified)
    Matching placebo tablet, administered once daily before the morning meal.
  • Experimental: sitagliptin
    Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
    Intervention: Drug: Comparator: sitagliptin phosphate
  • Placebo Comparator: Placebo
    Participants randomized to this arm will be administered matching placebo, daily for six weeks.
    Intervention: Drug: Comparator: placebo (unspecified)
Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant has type 2 diabetes mellitus
  • Males
  • Females who are highly unlikely to become pregnant
  • Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion Criteria:

  • Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Participant required insulin therapy within the prior 8 weeks
  • Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00704132
0431-059, 2006_511
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2013

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