The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

Diabetes Mellitus Non-insulin-dependent Clinical Trial

Official title:

Open-label, Non Placebo-Controlled Study To Verify the Effect of Sitagliptin In Adult Patients With Type 2 Diabetes and Inadequate Glycemic Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00832624
• Other study ID #: 0431-118
• Secondary ID: 2009_526
• Status: Terminated
• Phase: Phase 4
• First received: January 28, 2009
• Last updated: February 4, 2016
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

• Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)

• Or On A Single AHa

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Non-insulin-dependent
• Diabetes Mellitus, Type 2

Intervention

Drug:
• sitagliptin
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks

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 HbA1c (Hemoglobin A1c) at Week 18	Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.	Baseline and Week 18	Yes

External Links

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