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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3453 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-15

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Metformin + Sitagliptin

Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.

Metformin

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Metformin + Sulfonylurea

Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.

Metformin

Intervention Type DRUG

Sulfonylurea

Intervention Type DRUG

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.

Antihyperglycemic Medication

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Sulfonylurea

Intervention Type DRUG

Antihyperglycemic Medication

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No