Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

Type 2 Diabetes Clinical Trial

Official title:

A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541229
• Other study ID #: 0431-077
• Secondary ID: 2007_533
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2007
• Last updated: February 24, 2015
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient has Type 2 Diabetes

• Patient is between the ages of 30-65 years

• Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

• Patient has Type 1 Diabetes

• Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months

• Patient has taken insulin within the past 3 months

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• sitagliptin phosphate
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
• sitagliptin phosphate
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
• Comparator: Placebo
sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.

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	24-hour Weighted Mean Glucose (WMG)	The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.	Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.	No

External Links

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