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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545584
• Other study ID #: 0431-078
• Secondary ID: 2007_023
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2007
• Last updated: April 7, 2017
• Start date: April 1, 2007
• Est. completion date: November 19, 2009

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1512
• Est. completion date: November 19, 2009
• Est. primary completion date: November 19, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Drug:
• sitagliptin phosphate
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks

Behavioral:
• Comparator: Diet
Diet
• Comparator: Physical Activity
Physical Activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c Measurement	Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.	Baseline and Week 24
Secondary	Fasting Plasma Glucose (FPG) Measurement	Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).	Baseline and Week 24

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site