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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 is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01903356
First received: July 16, 2013
Last updated: May 19, 2017
Last verified: May 2017
  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 ]

Estimated Enrollment: 600
Actual Study Start Date: July 11, 2013
Estimated Study Completion Date: September 13, 2017
Estimated Primary Completion Date: September 13, 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903356

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Korea, Republic of
Recruiting
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
Study First Received: July 16, 2013
Last Updated: May 19, 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

ClinicalTrials.gov processed this record on May 25, 2017