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.
Verified April 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: April 2, 2014
Last verified: April 2014

July 16, 2013
April 2, 2014
July 2013
September 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01903356 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
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

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.

Study Design:

PMS Observational study

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Korean patients with T2DM

Diabetes Mellitus, Type 2
Drug: Trajenta duo
Linagliptin and Metformin
Patients with T2DM
Intervention: Drug: Trajenta duo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
September 2017
September 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Korea, Republic of
 
NCT01903356
1288.22
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP