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:

Merck

ClinicalTrials.gov Identifier:

NCT00545584

First received: October 16, 2007

Last updated: April 19, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 16, 2007

Last Updated Date

April 19, 2011

Start Date ^ICMJE

April 2007

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00545584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Non-Insulin-Dependent

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: 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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1512

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00545584

Other Study ID Numbers ^ICMJE

MK-0431-078, 2007_023

Has Data Monitoring Committee

Responsible Party

Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2011

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

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