The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
This study has been terminated.
Information provided by:
First received: January 28, 2009
Last updated: April 15, 2011
Last verified: April 2011
to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
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