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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

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ClinicalTrials.gov Identifier: NCT01707147
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

October 1, 2012
October 16, 2012
July 6, 2018
January 11, 2019
January 11, 2019
November 16, 2012
July 11, 2017   (Final data collection date for primary outcome measure)
Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta [ Time Frame: Up to 26 weeks (long-term surveillance) ]
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
Incidence of adverse events in patients who take at least one dose of Trajenta [ Time Frame: up to 24±2weeks ]
Complete list of historical versions of study NCT01707147 on ClinicalTrials.gov Archive Site
  • Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and Week 24 ]
    Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).
  • Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment [ Time Frame: 24 Weeks ]
    Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment.
  • Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) [ Time Frame: 24 Weeks ]
    Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).
  • Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 24 ]
    Change from baseline after 24 weeks in fasting plasma glucose (FPG).
  • 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 ]
  • Occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: up to 24±2weeks ]
  • Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: up to 24±2weeks ]
  • Change from baseline in Glucosylated Hemoglobin (HbA1c) after 24 weeks of treatment. [ Time Frame: up to 24±2weeks ]
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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
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:

Post Marketing study- Observational study

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Korean patients with T2DM
Diabetes Mellitus, Type 2
Drug: Trajenta tablet
Linagliptin
Patients with Type 2 Diabetes Mellitus
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.
 
Completed
3219
3000
July 11, 2017
July 11, 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 Patients who have signed on the data release consent form

Exclusion criteria:

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

Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01707147
1218.104
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2018