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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01357135
First received: May 18, 2011
Last updated: December 4, 2014
Last verified: December 2014

May 18, 2011
December 4, 2014
July 2009
August 2013   (final data collection date for primary outcome measure)
  • Median Duration (in Months) of Initial Dual Therapy [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Treatment Maintenance Duration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01357135 on ClinicalTrials.gov Archive Site
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An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)
Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).

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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

Participants with type II diabetes mellitus receiving a de novo prescription (for the first time or within less than 8 weeks) for dual therapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.

Type 2 Diabetes Mellitus
  • Drug: Metformin
  • Drug: Sitagliptin
  • Drug: Sulfonylurea
  • Drug: Antihyperglycemic Medication
  • Metformin + Sitagliptin
    Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
    Interventions:
    • Drug: Metformin
    • Drug: Sitagliptin
  • Metformin + Sulfonylurea
    Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
    Interventions:
    • Drug: Metformin
    • Drug: Sulfonylurea
  • 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.
    Intervention: Drug: Antihyperglycemic Medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3453
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01357135
0431-201
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP