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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01903356
First Posted: July 19, 2013
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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 Intervention
Diabetes Mellitus, Type 2 Drug: Trajenta duo

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 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

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 Duo [ Time Frame: up to 26 weeks ]

Secondary Outcome Measures:
  • Change from baseline in Glucosylated Hemoglobin (HbA1c) after 24 weeks of treatment [ Time Frame: up to 26 weeks ]
  • Occurence of treat to target effectiveness response, that is an Glucosylated Hemoglobin (HbA1c) under treatment of < 6.5% after 24 weeks of treatment [ Time Frame: up to 26 weeks ]
  • Occurence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: up to 26 weeks ]
  • Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: up to 26 weeks ]

Enrollment: 724
Actual Study Start Date: July 11, 2013
Study Completion Date: June 10, 2017
Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with T2DM Drug: Trajenta duo
Linagliptin and Metformin

Detailed Description:

Study Design:

PMS Observational study

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 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:

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
  Contacts and Locations
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
Korea, Republic of
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: NCT01903356     History of Changes
Other Study ID Numbers: 1288.22
First Submitted: July 16, 2013
First Posted: July 19, 2013
Last Update Posted: August 28, 2017
Last Verified: August 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