An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)
|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: NCT01357135|
Recruitment Status : Completed
First Posted : May 20, 2011
Results First Posted : December 5, 2014
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Drug: Metformin Drug: Sitagliptin Drug: Sulfonylurea Drug: Antihyperglycemic Medication|
|Study Type :||Observational|
|Actual Enrollment :||3453 participants|
|Official Title:||Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).|
|Actual Study Start Date :||July 15, 2009|
|Actual Primary Completion Date :||August 31, 2013|
|Actual Study Completion Date :||August 31, 2013|
Metformin + Sitagliptin
Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
Metformin + Sulfonylurea
Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
Sitagliptin +/- Other Antihyperglycemic Medication
Participants taking sitagliptin +/- other antihyperglycemic medication (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
Drug: Antihyperglycemic Medication
- Median Duration (in Months) of Initial Dual Therapy [ Time Frame: Up to 3 years ]The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.
- Percentage of Participants With Strict Changes in Initial Dual Therapy [ Time Frame: Up to 3 years ]Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.
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): NCT01357135
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|