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 August 2014 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: August 20, 2014
Last verified: August 2014
  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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Glucosylated Hemoglobin (HbA1c) after 24 weeks of treatment [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks) [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 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
Genders Eligible for Study:   Both
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
Boehringer Ingelheim Investigational Site 9 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 3 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 10 Recruiting
Choongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 4 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 5 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 2 Recruiting
Gyeongsangnam-do, Korea, Republic of
Boehringer Ingelheim Investigational Site 7 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 8 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 1 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 11 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 6 Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

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: August 20, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

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
Pharmacologic Actions
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 August 28, 2014