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 currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01707147
First received: October 1, 2012
Last updated: April 2, 2014
Last verified: April 2014
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: after 24±2weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: after 24±2weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: after 24±2weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: November 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 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
Genders Eligible for Study:   Both
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

Exclusion criteria:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707147

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 72 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

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: April 2, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
BI 1356
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014