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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. Identifier: NCT00541229
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : July 28, 2009
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: sitagliptin phosphate Drug: Comparator: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 24, 2007
Actual Primary Completion Date : June 17, 2008
Actual Study Completion Date : July 1, 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
sitagliptin 100 mg
Drug: sitagliptin phosphate
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
Other Name: MK0431

Experimental: 2
sitagliptin 200 mg
Drug: sitagliptin phosphate
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
Other Name: MK0431

Placebo Comparator: 3
Drug: Comparator: Placebo
sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541229

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00541229    
Other Study ID Numbers: 0431-077
First Posted: October 10, 2007    Key Record Dates
Results First Posted: July 28, 2009
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action