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 is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01707147

First received: October 1, 2012

Last updated: August 16, 2017

Last verified: August 2017

History of Changes

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:

Drug Information available for: Linagliptin

U.S. FDA Resources

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 ]


Estimated Enrollment:	3000
Actual Study Start Date:	November 16, 2012
Estimated Study Completion Date:	September 13, 2017
Estimated Primary Completion Date:	September 13, 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


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

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: NCT01707147

Locations


Korea, Republic of

One or Multiple Investigational Sites, 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
Study First Received:	October 1, 2012
Last Updated:	August 16, 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

ClinicalTrials.gov processed this record on September 21, 2017

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