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A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01707147
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Trajenta tablet

Detailed Description:

Study Design:

PMS Observational study


Study Design
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Study Type : Observational
Actual Enrollment : 2877 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)
Actual Study Start Date : November 16, 2012
Actual Primary Completion Date : July 11, 2017
Actual Study Completion Date : July 11, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients with T2DM Drug: Trajenta tablet
Linagliptin


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events in patients who take at least one dose of Trajenta [ Time Frame: up to 24±2weeks ]

Secondary Outcome Measures :
  1. Occurrence of treat to target effectiveness response, that is an Glycosylated Hemoglobin (HbA1c) under treatment of < 6.5% after 24 weeks of treatment. [ Time Frame: after 24±2weeks ]
  2. Occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: after 24±2weeks ]
  3. Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: after 24±2weeks ]
  4. Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: after 24±2weeks ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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:   Probability Sample
Study Population
Korean patients with T2DM
Criteria

Inclusion criteria:

Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form

Exclusion criteria:

Patients with previous exposure to Trajenta and current participation in clinical trials

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01707147


Locations
Korea, Republic of
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01707147     History of Changes
Other Study ID Numbers: 1218.104
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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