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

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 3, 2014
Last verified: September 2014
  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
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: 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 3, 2014
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
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 September 18, 2014