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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
July 16, 2013
July 19, 2013
August 28, 2017
July 11, 2013
May 30, 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 ]
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 ]
  • 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 ]
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
Observational Model: Other
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.
 
Completed
724
June 10, 2017
May 30, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01903356
1288.22
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2017