JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

NCT02848833 | Completed Results

• 1 other identifier: 1245.116
• Study Type: observational
• Target: 3,368
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Any Adverse Events

  Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

• Percentage of Participants With Adverse Events Relating to Study Drug

  Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

• Percentage of Participants With Unexpected Adverse Events

  Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

• Percentage of Participants With Adverse Events of Special Interest

  Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: * Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection * Increased urination * Urinary tract infection (UTI) * Volume depletion * Diabetic Ketoacidosis (DKA) * Decreased renal function: * Hepatic injury * Lower limb amputation

  From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

• Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug

  Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Secondary Outcomes (8)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit

  At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

• Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit

  At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

• Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit

  At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

• Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit

  At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

• Change From Baseline in Body Weight at Last Visit

  At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Study Arms (1)

JARDIANCE

T2DM with JARDIANCE

Drug: JARDIANCE 10mg; Drug: JARDIANCE 25mg

Interventions

JARDIANCE 10mg DRUG

T2DM with JARDIANCE 10mg

JARDIANCE

JARDIANCE 25mg DRUG

MT2DM with JARDIANCE 25mgax

JARDIANCE

Eligibility Criteria

• Age: 19 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

type 2 diabetes mellitus in Korea

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 29, 2016
• Study Start: August 10, 2016
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

KR (1)