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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357135
• Other study ID #: 0431-201
• Status: Completed
• Phase: N/A
• First received: May 18, 2011
• Last updated: December 11, 2015
• Start date: July 2009
• Est. completion date: August 2013

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3453
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin

• Sitagliptin

• Sulfonylurea

• Antihyperglycemic Medication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Valensi P, de Pouvourville G, Benard N, Chanut-Vogel C, Kempf C, Eymard E, Moisan C, Dallongeville J. Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study. Diabetes Metab. 2015 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No