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Completed

NCT Number: NCT01357135

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

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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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

Sitagliptin

Drug

Sulfonylurea

Drug

Antihyperglycemic medication

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 20, 2011
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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