Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00545584
First received: October 16, 2007
Last updated: September 24, 2013
Last verified: September 2013

October 16, 2007
September 24, 2013
April 2007
November 2009   (final data collection date for primary outcome measure)
Hemoglobin A1c Measurement [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.
Not Provided
Complete list of historical versions of study NCT00545584 on ClinicalTrials.gov Archive Site
Fasting Plasma Glucose (FPG) Measurement [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).
Not Provided
Not Provided
Not Provided
 
Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)(COMPLETED)
Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
  • Drug: sitagliptin phosphate
    sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
  • Behavioral: Comparator: Diet
    Diet
  • Behavioral: Comparator: Physical Activity
    Physical Activity
  • Experimental: Sitagliptin with Standard of Care
    Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
    Intervention: Drug: sitagliptin phosphate
  • Experimental: Sitagliptin with Diet Advice

    Subjects received sitagliptin 100 mg once daily for 26 Weeks,

    and:

    Intervention on diet which includes advice on diet with a leaflet and a diary

    Interventions:
    • Drug: sitagliptin phosphate
    • Behavioral: Comparator: Diet
  • Experimental: Sitagliptin with Diet and Physical Activity Advice

    Subjects received sitagliptin 100 mg once daily for 26 Weeks,

    and:

    Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

    Interventions:
    • Drug: sitagliptin phosphate
    • Behavioral: Comparator: Diet
    • Behavioral: Comparator: Physical Activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1512
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)

Exclusion Criteria:

  • Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
  • Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
  • Known hypersensitivity or contraindication to metformin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00545584
0431-078, 2007_023
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2013

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