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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 5, 2007
Last updated: April 7, 2017
Last verified: April 2017
A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes Drug: sitagliptin phosphate Drug: Comparator: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.

Enrollment: 103
Actual Study Start Date: August 24, 2007
Study Completion Date: July 1, 2008
Primary Completion Date: June 17, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   30 Years to 65 Years   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00541229

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00541229     History of Changes
Other Study ID Numbers: 0431-077
Study First Received: October 5, 2007
Results First Received: June 5, 2009
Last Updated: April 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
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 processed this record on September 19, 2017