A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea

Completed

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

• Registration Number: NCT01903356
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.

Detailed Description

Study Design:

Post Marketed Study- Observational study

Study Timeline

• Study Start: 2013-07-11
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Primary Completion: 2017-05-30
• Study Completion: 2017-06-10
• Status Verified: 2018-06
• Results First Submitted: 2018-06-08
• Results First Submitted QC: 2018-06-08
• Last Update Submitted: 2018-06-08
• Results First Posted: 2018-12-21
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 724

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with T2DM	Trajenta duo	-

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Adverse Events (AE)	Up to 26 weeks	The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo

Secondary Outcome Measures

Name	Time	Method
Relative Effectiveness Response Rate	24 Weeks	Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.	24 Weeks	This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication.
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.	Baseline and Week 24	This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
Target Effectiveness Response Rate	24 Weeks	Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \< 6.5% after 24 weeks.