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
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: 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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014