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. Identifier: NCT01357135
Recruitment Status : Completed
First Posted : May 20, 2011
Results First Posted : December 5, 2014
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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
Observational Model: Other
Time Perspective: Prospective
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
Primary Completion Date : August 31, 2013
Study Completion Date : August 31, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Metformin + Sitagliptin
Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
Drug: Metformin Drug: Sitagliptin
Metformin + Sulfonylurea
Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
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.
Drug: Antihyperglycemic Medication

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01357135

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01357135     History of Changes
Other Study ID Numbers: 0431-201
First Posted: May 20, 2011    Key Record Dates
Results First Posted: December 5, 2014
Last Update Posted: June 5, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action