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Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541229
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : July 28, 2009
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 10, 2007
Results First Submitted Date  ICMJE June 5, 2009
Results First Posted Date  ICMJE July 28, 2009
Last Update Posted Date May 12, 2017
Actual Study Start Date  ICMJE August 24, 2007
Actual Primary Completion Date June 17, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
24-hour Weighted Mean Glucose (WMG) [ Time Frame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only. ]
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
To evaluate the 24 hour weighted mean glucose (WMG)-lowering efficacy on sitagliptin 100mg compared to 200mg [ Time Frame: 24 Hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
Safety and Efficacy of Sitagliptin as compared to placebo.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Official Title  ICMJE A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise
Brief Summary A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: sitagliptin phosphate
    sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
    Other Name: MK0431
  • Drug: sitagliptin phosphate
    sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
    Other Name: MK0431
  • Drug: Comparator: Placebo
    sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Study Arms  ICMJE
  • Experimental: 1
    sitagliptin 100 mg
    Intervention: Drug: sitagliptin phosphate
  • Experimental: 2
    sitagliptin 200 mg
    Intervention: Drug: sitagliptin phosphate
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Comparator: Placebo
Publications * Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2009)
103
Original Enrollment  ICMJE
 (submitted: October 5, 2007)
90
Actual Study Completion Date  ICMJE July 1, 2008
Actual Primary Completion Date June 17, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has Type 2 Diabetes
  • Patient is between the ages of 30-65 years
  • Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

  • Patient has Type 1 Diabetes
  • Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
  • Patient has taken insulin within the past 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Austria,   Germany,   Mexico,   Norway,   Sweden,   United States
 
Administrative Information
NCT Number  ICMJE NCT00541229
Other Study ID Numbers  ICMJE 0431-077
2007_533
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2017

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