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

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ClinicalTrials.gov Identifier: NCT01903356
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Trajenta duo

Detailed Description:

Study Design:

Post Marketed Study- Observational study


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Study Type : Observational
Actual Enrollment : 724 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : July 11, 2013
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : June 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Group/Cohort Intervention/treatment
Patients with T2DM Drug: Trajenta duo
Linagliptin and Metformin




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean patients with T2DM
Criteria

Inclusion criteria:

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

  1. No previous exposure to Trajenta, Trajenta Duo
  2. Should have been started on Trajenta Duo in accordance with the approved label in Korea
  3. No current participation in clinical trials
  4. No metformin is inappropriate due to contraindications
  5. 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:

  1. Previous exposure to Trajenta, Trajenta Duo
  2. Current participation in clinical trials
  3. Patients for whom metformin is inappropriate due to contraindications

Information from the National Library of Medicine

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): NCT01903356


Locations
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Korea, Republic of
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01903356     History of Changes
Other Study ID Numbers: 1288.22
First Posted: July 19, 2013    Key Record Dates
Results First Posted: December 21, 2018
Last Update Posted: December 21, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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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