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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707147
First Posted: October 16, 2012
Last Update Posted: November 16, 2017
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.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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 Intervention
Diabetes Mellitus, Type 2 Drug: Trajenta tablet

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Secondary Outcome Measures:
  • 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 ]
  • Occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: after 24±2weeks ]
  • Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: after 24±2weeks ]
  • Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: after 24±2weeks ]

Enrollment: 2877
Actual Study Start Date: November 16, 2012
Study Completion Date: July 11, 2017
Primary Completion Date: July 11, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with T2DM Drug: Trajenta tablet
Linagliptin

Detailed Description:

Study Design:

PMS Observational study

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01707147     History of Changes
Other Study ID Numbers: 1218.104
First Submitted: October 1, 2012
First Posted: October 16, 2012
Last Update Posted: November 16, 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