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Completed

NCT Number: NCT01062048

Januvia Re-examination Study (MK-0431-181)

The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

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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

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 Mellitus
  • Treated With Januvia within local label for the first time

Exclusion criteria

  • Contraindication to Januvia according to the local label
  • Treated with Januvia before contract and out of enrollment period

Inclusion criteria

for long-term surveillance

  • Treated with Januvia for more than or equal to 24 weeks

Treatment and study plan

Sitagliptin

Drug

Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label

Other names: Januvia

Sulfonylurea

Drug

Sulfonylurea administered in general use according to the local label

Insulin

Biological

Insulin administered in general use according to the local label

Primary outcomes

  1. Percentage of participants with any adverse experience

    Time frame: up to 14 days following cessation of treatment

  2. Mean change in Hemoglobin A1c (HbA1c)

    Time frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment

  3. Mean change in fasting plasma glucose (FPG)

    Time frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment

  4. Mean change in 2hr-postprandial glucose (PPG)

    Time frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2010
Registry last updated
Feb 5, 2016

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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