ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 187 for:    BI10773

JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02848833
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: JARDIANCE 10mg Drug: JARDIANCE 25mg

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : August 10, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
JARDIANCE
T2DM with JARDIANCE
Drug: JARDIANCE 10mg
T2DM with JARDIANCE 10mg

Drug: JARDIANCE 25mg
MT2DM with JARDIANCE 25mgax




Primary Outcome Measures :
  1. All reported adverse events in patients who take at least one dose of JARDIANCE® will be noted. [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. Change from baseline in HbA1c after 12 weeks and/or 24 weeks of treatment [ Time Frame: 24weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
type 2 diabetes mellitus in Korea
Criteria

Inclusion criteria:

  1. Patients who have been started on JARDIANCE® in accordance with the approved label in Korea
  2. Age = 19 years at enrolment
  3. Patients who have signed on the data release consent form

Exclusion criteria:

  1. Known hypersensitivity to empagliflozin or any of its excipients
  2. Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
  3. Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
  4. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  5. Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

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): NCT02848833


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

Locations
Korea, Republic of
Recruiting
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02848833     History of Changes
Other Study ID Numbers: 1245.116
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs