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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: sitagliptin phosphate
Behavioral: Comparator: Diet
Behavioral: Comparator: Physical Activity
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 1512
Study Start Date: April 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
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

Drug: sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
Behavioral: Comparator: Diet
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.

Drug: sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
Behavioral: Comparator: Diet
Diet
Behavioral: Comparator: Physical Activity
Physical Activity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545584

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

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00545584     History of Changes
Other Study ID Numbers: 0431-078, 2007_023
Study First Received: October 16, 2007
Results First Received: April 19, 2011
Last Updated: September 24, 2013
Health Authority: France: Ministry of Health

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 16, 2014