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Clinical Trial Details

Trial ID: L4262
Source ID: NCT03642717
Associated Drug: Jardiance Duo®
Title: Regulatory Request NIS in Korea
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03642717/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: JARDIANCE DUO®
Outcome Measures: Primary: 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 event was calculated by Exact Method., From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 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 event was calculated by Exact Method., From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 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 event was calculated by Exact Method., From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.|Percentage of Participants With Adverse Events of Special Interest, Percentage of participants with adverse events of special interest was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method., From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 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 event was calculated by Exact Method., From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days. | Secondary: Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline, Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported., At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit, Number of participants reached target effectiveness response in the glycosylated hemoglobin (HbA1c) (HbA1c \< 7%) at Last Visit was reported. Target effectiveness response in the glycosylated hemoglobin (HbA1c) was defined as HbA1c less than 7%., At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit, Number of participants with relative effectiveness response in the glycosylated hemoglobin (HbA1c) at Last Visit was reported. Relative effectiveness response in the glycosylated hemoglobin (HbA1c) at last visit was defined as HbA1c decrease of 0.5% or more at the last visit comparing to baseline., At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline, Change in the Fasting Plasma Glucose (FPG) at Last Visit from baseline was reported., At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Change in the Body Weight at Last Visit From Baseline, Change in the body weight at Last Visit from baseline was reported., At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline, Change in the systolic blood pressure (SBP) at Last Visit from baseline was reported., At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline, Change in the diastolic blood pressure (DBP) at Last Visit from baseline was reported., At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).|Number of Participants Per Final Effectiveness Assessment Category at Last Visit, Number of participants per final effectiveness assessment category at Last Visit was reported. The final effectiveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.)., At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 658
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-08-21
Completion Date: 2020-04-30
Results First Posted: 2021-05-21
Last Update Posted: 2021-05-21
Locations: Korea University Ansan Hospital, Ansan, 15355, Korea, Republic of|Hyewon Medical Foundation Sejong Hospital, Bucheon, 14754, Korea, Republic of|Inje University Busan Paik Hospital, Busan, 47392, Korea, Republic of|Inje University Haeundae Paik Hospital, Busan, 48108, Korea, Republic of|Keimyung University Dongsan Hospital, Daegu, 41931, Korea, Republic of|Eulji University Hospital, Daejeon, 35233, Korea, Republic of|Myongji Hospital, Goyang, 10475, Korea, Republic of|Chonnam National University Hospital, Gwangju, 61469, Korea, Republic of|Gachon University Gil Medical Center, Incheon, 21565, Korea, Republic of|Inha University Hospital, Incheon, 22332, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam, 13620, Korea, Republic of|Inje University Sanggye Paik Hospital, Seoul, 01757, Korea, Republic of|Seoul Medical Center, Seoul, 02053, Korea, Republic of|Kyung Hee University Hospital, Seoul, 02447, Korea, Republic of|SoonChunHyang University Seoul Hospital, Seoul, 04404, Korea, Republic of|Hanyang University Seoul Hospital, Seoul, 04763, Korea, Republic of|Hallym University Kangnam Sacred Heart Hospital, Seoul, 07441, Korea, Republic of|Hongik Hospital, Seoul, 07937, Korea, Republic of|Ajou University Hospital, Suwon, 16499, Korea, Republic of|Yonsei University Wonju Severance Christian Hospital, Wonju, 26426, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03642717