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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Trajenta tablet

• Registration Number: NCT01707147
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Study Design:

Post Marketing study- Observational study

Study Timeline

• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2012-11-16
• Primary Completion: 2017-07-11
• Study Completion: 2017-07-11
• Status Verified: 2018-07
• Results First Submitted: 2018-07-06
• Results First Submitted QC: 2018-07-06
• Last Update Submitted: 2018-07-06
• Results First Posted: 2019-01-11
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3219

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Type 2 Diabetes Mellitus	Trajenta tablet	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)	Baseline and Week 24	Change from baseline after 24 weeks in fasting plasma glucose (FPG).
Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment	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)	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 Glycosylated Hemoglobin (HbA1c)	Baseline and Week 24	Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).