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Completed

NCT Number: NCT01903356

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, South Korea

About this study

Study Design:

Post Marketed Study- Observational study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Potential subjets must meet all of the following inclusion criteria to enter this trial:

  • No previous exposure to Trajenta, Trajenta Duo
  • Should have been started on Trajenta Duo in accordance with the approved label in Korea
  • No current participation in clinical trials
  • No metformin is inappropriate due to contraindications
  • Must sign on the data release consent form

Exclusion criteria

Individuals with any of the following characteristics will not be able to enter this study:

  • Previous exposure to Trajenta, Trajenta Duo
  • Current participation in clinical trials
  • Patients for whom metformin is inappropriate due to contraindications

Treatment and study plan

Trajenta duo

Drug

Linagliptin and Metformin

Primary outcomes

  1. Incidence Rate of Adverse Events (AE)

    Time frame: 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 outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.

    Time frame: 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.

  2. Target Effectiveness Response Rate

    Time frame: 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.

  3. Relative Effectiveness Response Rate

    Time frame: 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.

  4. Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2013
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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