An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

Study Overview
=================
Brief Summary
-----------------
This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.

Official Title
-----------------
Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Sitagliptin
* Drug: Sulfonylurea
* Drug: Antihyperglycemic Medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes participants De novo treatment (first prescription or dated within the past 8 weeks) with: Metformin + sitagliptin dual therapy, Metformin + sulfonylurea dual therapy, Sitagliptin as part of another treatment regimen Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metformin + Sitagliptin<br>Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice. | Drug: Metformin<br> <br> Drug: Sitagliptin<br> <br> |
| Metformin + Sulfonylurea<br>Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride. | Drug: Metformin<br> <br> Drug: Sulfonylurea<br> <br> |
| Sitagliptin +/- Other Antihyperglycemic Medication<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Duration (in Months) of Initial Dual Therapy | 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. | Up to 3 years | 
| Percentage of Participants With Strict Changes in Initial Dual Therapy | 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. | Up to 3 years |