A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy|
- Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
- Change From Baseline in Fasting Plasma Glucose at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]Calculated as the mean change from baseline in fasting plasma glucose at Week 4.
|Study Start Date:||March 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Sitagliptin as add-on therapy to a stable dose of metformin
Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
Other Names:Drug: Metformin
Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Other Name: Glucophage