Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title:

A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704132
• Other study ID #: 0431-059
• Secondary ID: 2006_511
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2008
• Last updated: August 13, 2015
• Start date: February 2007
• Est. completion date: April 2010

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participant has type 2 diabetes mellitus

• Males

• Females who are highly unlikely to become pregnant

• Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion Criteria:

• Participant has a history of type 1 diabetes mellitus or history of ketoacidosis

• Participant required insulin therapy within the prior 8 weeks

• Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Comparator: sitagliptin phosphate
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
• Comparator: placebo (unspecified)
Matching placebo tablet, administered once daily before the morning meal.

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	Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6	Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.	Baseline and Week 6	No

External Links

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