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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00704132
First received: June 23, 2008
Last updated: April 21, 2011
Last verified: April 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704132

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00704132     History of Changes
Other Study ID Numbers: MK-0431-059, 2006_511
Study First Received: June 23, 2008
Results First Received: April 21, 2011
Last Updated: April 21, 2011
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013