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

October 1, 2012
April 2, 2014
November 2012
September 2017   (final data collection date for primary outcome measure)
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 ]
Incidence of adverse events in patients who take at least one dose of Trajenta [ Time Frame: up to 24±2weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01707147 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Occurrence of treat to target effectiveness response, that is an Glucosylated Hemoglobin (HbA1c) under treatment of < 6.5% after 24 weeks of treatment. [ Time Frame: up to 24±2weeks ] [ Designated as safety issue: No ]
  • Occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: up to 24±2weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: up to 24±2weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Glucosylated Hemoglobin (HbA1c) after 24 weeks of treatment. [ Time Frame: up to 24±2weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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)

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.

Study Design:

PMS Observational study

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Korean patients with T2DM

Diabetes Mellitus, Type 2
Drug: Trajenta tablet
Linagliptin
Patients with T2DM
Intervention: Drug: Trajenta tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
September 2017
September 2017   (final data collection date for primary outcome measure)

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

Both
19 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Korea, Republic of
 
NCT01707147
1218.104
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP