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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
This study is currently recruiting participants.
Verified June 2017 by Boehringer Ingelheim
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01707147
First received: October 1, 2012
Last updated: June 21, 2017
Last verified: June 2017
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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: | 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) |
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 ]
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 ]
- 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 ]
| Estimated Enrollment: | 3000 |
| Actual Study Start Date: | November 16, 2012 |
| Estimated Study Completion Date: | September 13, 2017 |
| Estimated Primary Completion Date: | September 13, 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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 Patients who have signed on the data release consent form
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
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 |
Locations
| Korea, Republic of | |
| Recruiting | |
| One or Multiple Investigational Sites, Korea, Republic of | |
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
| 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: | June 21, 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 |
ClinicalTrials.gov processed this record on June 22, 2017