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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00337610
First received: June 14, 2006
Last updated: May 27, 2010
Last verified: May 2010
History of Changes

June 14, 2006
May 27, 2010
June 2006
May 2007   (final data collection date for primary outcome measure)
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.
HbA1c after 18 weeks, safety and tolerability
Complete list of historical versions of study NCT00337610 on ClinicalTrials.gov Archive Site
  • 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.
2-hour PPG and FPG after 18 weeks
Not Provided
Not Provided
 
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus (T2DM)
  • 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
  • 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.
  • Experimental: sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day
    Intervention: Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
  • Placebo Comparator: sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day
    Intervention: Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
August 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00337610
2006_017, MK0431-053
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP