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
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Drug: Metformin
Drug: Sitagliptin
Drug: Sulfonylurea
Drug: Antihyperglycemic Medication

Study Type: Observational
Study Design: 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®).

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Enrollment: 3453
Study Start Date: July 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357135

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357135     History of Changes
Other Study ID Numbers: 0431-201
Study First Received: May 18, 2011
Results First Received: November 14, 2014
Last Updated: December 4, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission

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

ClinicalTrials.gov processed this record on August 27, 2015