Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541775
• Other study ID #: 0431-801
• Secondary ID: 2007_623
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: August 21, 2015
• Start date: June 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient has Type 2 diabetes

• Currently taking metformin >1500 mg/day for at least 10 weeks

• Male or female

Exclusion Criteria:

• Patient has peripheral edema

• History of type 1 diabetes

• Patient required insulin within prior 8 weeks

• Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study

• Participating in a weight loss program

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
• Comparator: Rosiglitazone
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
• Comparator: Placebo
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
• Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C (A1C) at Week 18	A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.; The study hypothesis comparison was between sitagliptin versus placebo.	Baseline and 18 Weeks	No
Secondary	Fasting Plasma Glucose (FPG) at Week 18	The change from baseline is the Week 18 FPG minus the Week 0 FPG.	Baseline and 18 Weeks	No
Secondary	2-hour Post-meal Glucose (PMG) at Week 18	The change from baseline is the Week 18 PMG minus the Week 0 PMG.	Baseline and 18 Weeks	No

External Links

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