A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||October 4, 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034111
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|