Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
|ClinicalTrials.gov Identifier: NCT00875394|
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : April 20, 2011
Last Update Posted : May 30, 2017
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Diabetes Mellitus, Non-Insulin-Dependent
Drug: sitagliptin phosphate
Drug: Comparator: metformin
Drug: Comparator: Antidiabetic Standard of Care
Patients were recruited in Principal Investigator's private practice, in Mexico City.
First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008
|Pre-assignment Details||Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or "standard care" added to ongoing metformin.|
A limited number of participants were recruited into this open-label study. This study was conducted at a single site.
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.