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

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: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Drug: Comparator: sitagliptin phosphate
Drug: Comparator: placebo (unspecified)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Enrollment: 57
Study Start Date: February 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sitagliptin
Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
Drug: Comparator: sitagliptin phosphate
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
Placebo Comparator: Placebo
Participants randomized to this arm will be administered matching placebo, daily for six weeks.
Drug: Comparator: placebo (unspecified)
Matching placebo tablet, administered once daily before the morning meal.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00704132

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

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704132     History of Changes
Other Study ID Numbers: 0431-059, 2006_511
Study First Received: June 23, 2008
Results First Received: April 21, 2011
Last Updated: September 5, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 21, 2014