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. (see Contacts and Locations)
Verified September 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: September 17, 2014
Last verified: September 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
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

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

  Hide Study Locations
Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 35 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 72 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 47 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 66 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 51 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 11 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 16 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 59 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 22 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 14 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 61 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 49 Recruiting
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 33 Recruiting
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 23 Recruiting
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 46 Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 10 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 9 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 67 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 13 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 34 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 40 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 63 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 36 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 21 Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 53 Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 50 Recruiting
Gwangwon, Korea, Republic of
Boehringer Ingelheim Investigational Site 17 Recruiting
Gyeongbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 29 Recruiting
Gyeongbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 25 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 30 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 31 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 2 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 7 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 27 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 3 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 20 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 37 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 39 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 42 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 68 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 48 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 15 Recruiting
Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 60 Recruiting
Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 43 Recruiting
Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 5 Recruiting
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 26 Recruiting
Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 62 Recruiting
Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 38 Recruiting
Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 45 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 18 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 44 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 52 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 1 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 54 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 32 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 19 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 57 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 58 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 8 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 28 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 6 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 24 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 41 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 64 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 65 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 4 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 12 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 55 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 69 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 70 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 71 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 56 Recruiting
Ulsan, Korea, Republic of
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: September 17, 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
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
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 18, 2014