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
Last Update Posted
: November 17, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Diabetes Mellitus, Type 2 | Drug: Trajenta tablet |
Study Design:
PMS Observational study
Study Type : | Observational |
Actual Enrollment : | 2877 participants |
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) |
Actual Study Start Date : | November 16, 2012 |
Actual Primary Completion Date : | July 11, 2017 |
Actual Study Completion Date : | July 11, 2017 |

Group/Cohort | Intervention/treatment |
---|---|
Patients with T2DM |
Drug: Trajenta tablet
Linagliptin
|
- Incidence of adverse events in patients who take at least one dose of Trajenta [ Time Frame: up to 24±2weeks ]
- 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 ]

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707147
Korea, Republic of | |
Multiple Locations, Korea, Republic of |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01707147 History of Changes |
Other Study ID Numbers: |
1218.104 |
First Posted: | October 16, 2012 Key Record Dates |
Last Update Posted: | November 17, 2017 |
Last Verified: | November 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 |