Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337610
First received: June 14, 2006
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.


Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in A1C at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.


Secondary Outcome Measures:
  • Change From Baseline in FPG at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.

  • Change From Baseline in 2 Hr-PMG at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Change from baseline at Week 18 is defined as Week 18 minus Week 0.

  • Change From Baseline in A1C at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
    A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.


Enrollment: 190
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
Other Name: Januvia
Placebo Comparator: sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Males
  • Females who are highly unlikely to become pregnant
  • Patients poorly controlled while taking one or two oral antidiabetic medications

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient required insulin therapy within the prior 8 weeks
  • Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337610

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

Additional Information:
Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00337610     History of Changes
Other Study ID Numbers: 2006_017, MK0431-053
Study First Received: June 14, 2006
Results First Received: September 24, 2009
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014