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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. Read our disclaimer for details. Identifier: NCT02848833
Recruitment Status : Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : February 13, 2020
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

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Study Type : Observational
Actual Enrollment : 3377 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 : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

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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

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 identifier (NCT number): NCT02848833

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

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Responsible Party: Boehringer Ingelheim Identifier: NCT02848833    
Other Study ID Numbers: 1245.116
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs