A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
|ClinicalTrials.gov Identifier: NCT01034111|
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : November 7, 2011
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Sitagliptin phosphate Drug: Metformin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 1, 2010|
|Primary Completion Date :||October 4, 2010|
|Study Completion Date :||October 4, 2010|
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
- Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment [ Time Frame: 4 weeks ]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 ]Calculated as the mean change from baseline in fasting plasma glucose at Week 4.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034111
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|