JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02848833
Collaborator
(none)
3,368
Enrollment
1
Location
44.2
Actual Duration (Months)
76.2
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Drug: JARDIANCE 10mg
  • Drug: JARDIANCE 25mg

Study Design

Study Type:
Observational
Actual Enrollment :
3368 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 :
Aug 10, 2016
Actual Primary Completion Date :
Apr 17, 2020
Actual Study Completion Date :
Apr 17, 2020

Arms and Interventions

ArmIntervention/Treatment
JARDIANCE

T2DM with JARDIANCE

Drug: JARDIANCE 10mg
T2DM with JARDIANCE 10mg

Drug: JARDIANCE 25mg
MT2DM with JARDIANCE 25mgax

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Any Adverse Events [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 any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  2. Percentage of Participants With Adverse Events Relating to Study Drug [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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  3. Percentage of Participants With Unexpected Adverse Events [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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

  4. Percentage of Participants With Adverse Events of Special Interest [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 (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

  5. Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug [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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

Secondary Outcome Measures

  1. 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).]

    Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.

  2. 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 who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.

  3. 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).]

    Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit

  4. 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 fasting plasma glucose (FPG) at last visit.

  5. 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).]

    Change from baseline in body weight at last visit.

  6. Change From Baseline in Systolic Blood Pressure (SBP) 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 systolic blood pressure (SBP) at last visit.

  7. Change From Baseline in Diastolic Blood Pressure (DBP) 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 diastolic blood pressure (DBP) at last visit.

  8. Number of Participants Per Final Effectiveness Assessment Category at Last Visit [At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

    Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness 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.).

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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®

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Multiple LocationsKorea, Republic of

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02848833
Other Study ID Numbers:
  • 1245.116
First Posted:
Jul 29, 2016
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021

Study Results

Participant Flow

Recruitment DetailsThis was and observational prospective, non-interventional, open-label, multi-centre study to monitor the safety profile and efficacy of JARDIANCE® (empagliflozin, 10 milligram (mg), 25mg) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.
Pre-assignment DetailAll subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Period Title: Overall Study
STARTED3368
COMPLETED3231
NOT COMPLETED137

Baseline Characteristics

Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Overall Participants3231
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
56.66
(11.60)
Sex: Female, Male (Count of Participants)
Female
1380
42.7%
Male
1851
57.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
TitlePercentage of Participants With Any Adverse Events
DescriptionPercentage 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.
Time FrameFrom baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants3231
Number (95% Confidence Interval) [Percentage of participants]
13.93
0.4%
2. Primary Outcome
TitlePercentage of Participants With Adverse Events Relating to Study Drug
DescriptionPercentage 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.
Time FrameFrom baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants3231
Number (95% Confidence Interval) [Percentage of participants]
5.14
0.2%
3. Primary Outcome
TitlePercentage of Participants With Unexpected Adverse Events
DescriptionPercentage 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.
Time FrameFrom baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants3231
Number (95% Confidence Interval) [Percentage of participants]
11.54
0.4%
4. Primary Outcome
TitlePercentage of Participants With Adverse Events of Special Interest
DescriptionPercentage 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
Time FrameFrom baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants3231
Number (95% Confidence Interval) [Percentage of participants]
1.45
0%
5. Primary Outcome
TitlePercentage of Participants With Adverse Events Leading to Discontinuation of the Drug
DescriptionPercentage 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.
Time FrameFrom baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants3231
Number (95% Confidence Interval) [Percentage of participants]
3.25
0.1%
6. Secondary Outcome
TitleChange From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
DescriptionChange from baseline in glycosylated hemoglobin (HbA1c) at last visit.
Time FrameAt baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2567
Mean (Standard Deviation) [Percentage of glycosylated hemoglobin]
-0.68
(1.39)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JARDIANCE®
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value<0.0001
CommentsDifference before administration versus after administration was analyzed using a paired t-test.
Methodpaired t-test
Comments
7. Secondary Outcome
TitleNumber of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
DescriptionNumber of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.
Time FrameAt the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2567
lower than 7%
1132
35%
greater than or equal to 7%
1435
44.4%
8. Secondary Outcome
TitleNumber of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
DescriptionNumber of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit
Time FrameAt baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2567
greater than or equal to 0.5%
1315
40.7%
lower than 0.5%
1252
38.7%
9. Secondary Outcome
TitleChange From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
DescriptionChange from baseline in fasting plasma glucose (FPG) at last visit.
Time FrameAt baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2160
Mean (Standard Deviation) [milligram per deciliter (mg/dl)]
-25.59
(59.84)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JARDIANCE®
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value<0.0001
CommentsDifference before administration versus after administration was analyzed using a paired t-test.
Methodpaired t-test
Comments
10. Secondary Outcome
TitleChange From Baseline in Body Weight at Last Visit
DescriptionChange from baseline in body weight at last visit.
Time FrameAt baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2097
Mean (Standard Deviation) [kilogram]
-1.91
(3.37)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JARDIANCE®
Comments
Type of Statistical Test Other
Comments Difference before administration versus after administration was analyzed using a paired t-test.
Statistical Test of Hypothesisp-Value<0.0001
Comments
Methodpaired t-test
Comments
11. Secondary Outcome
TitleChange From Baseline in Systolic Blood Pressure (SBP) at Last Visit
DescriptionChange from baseline in systolic blood pressure (SBP) at last visit.
Time FrameAt baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2355
Mean (Standard Deviation) [millimeters of mercury (mmHg)]
-3.95
(15.44)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JARDIANCE®
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value<0.0001
CommentsDifference before administration versus after administration was analyzed using a paired t-test.
Methodpaired t-test
Comments
12. Secondary Outcome
TitleChange From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
DescriptionChange from baseline in diastolic blood pressure (DBP) at last visit.
Time FrameAt baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2354
Mean (Standard Deviation) [millimeters of mercury (mmHg)]
-1.80
(10.82)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JARDIANCE®
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value<0.0001
CommentsDifference before administration versus after administration was analyzed using a paired t-test.
Methodpaired t-test
Comments
13. Secondary Outcome
TitleNumber of Participants Per Final Effectiveness Assessment Category at Last Visit
DescriptionNumber of participants per final effectiveness assessment category at last visit was reported. The final effeciveness 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.).
Time FrameAt the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description
Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants2567
Improved
1749
54.1%
Unchanged
546
16.9%
Aggravated
195
6%
Unassessable
77
2.4%

Adverse Events

Time FrameFrom baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Adverse Event Reporting Description Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group TitleJARDIANCE®
Arm/Group DescriptionJARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
All Cause Mortality
JARDIANCE®
Affected / at Risk (%)# Events
Total0/3231 (0%)
Serious Adverse Events
JARDIANCE®
Affected / at Risk (%)# Events
Total55/3231 (1.7%)
Cardiac disorders
Angina pectoris1/3231 (0%)
Angina unstable4/3231 (0.1%)
Coronary artery disease1/3231 (0%)
Prinzmetal angina2/3231 (0.1%)
Eye disorders
Glaucoma1/3231 (0%)
Pathologic myopia1/3231 (0%)
Retinal detachment1/3231 (0%)
Retinal vein occlusion1/3231 (0%)
Rhegmatogenous retinal detachment1/3231 (0%)
Gastrointestinal disorders
Colitis1/3231 (0%)
Colitis ischaemic1/3231 (0%)
Diarrhoea1/3231 (0%)
Gastric ulcer1/3231 (0%)
Large intestinal haemorrhage1/3231 (0%)
Nausea1/3231 (0%)
Vomiting1/3231 (0%)
General disorders
Pyrexia1/3231 (0%)
Vascular stent stenosis1/3231 (0%)
Vascular stent thrombosis1/3231 (0%)
Hepatobiliary disorders
Autoimmune hepatitis1/3231 (0%)
Cholecystitis acute1/3231 (0%)
Cholelithiasis1/3231 (0%)
Infections and infestations
Appendiceal abscess1/3231 (0%)
Appendicitis1/3231 (0%)
Cellulitis1/3231 (0%)
Meningitis1/3231 (0%)
Otitis media chronic1/3231 (0%)
Peritonsillar abscess1/3231 (0%)
Pneumonia1/3231 (0%)
Pulmonary tuberculosis1/3231 (0%)
Pyelonephritis acute1/3231 (0%)
Sepsis1/3231 (0%)
Subcutaneous abscess1/3231 (0%)
Tubo-ovarian abscess1/3231 (0%)
Vestibular neuronitis1/3231 (0%)
Injury, poisoning and procedural complications
Limb injury1/3231 (0%)
Road traffic accident1/3231 (0%)
Splenic injury1/3231 (0%)
Sternal fracture1/3231 (0%)
Investigations
Alanine aminotransferase increased1/3231 (0%)
Aspartate aminotransferase increased1/3231 (0%)
Metabolism and nutrition disorders
Diabetes mellitus1/3231 (0%)
Hyperglycaemia3/3231 (0.1%)
Hyponatraemia1/3231 (0%)
Musculoskeletal and connective tissue disorders
Back pain1/3231 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of ampulla of Vater1/3231 (0%)
Benign ovarian tumour1/3231 (0%)
Bladder cancer1/3231 (0%)
Gastric cancer1/3231 (0%)
Pancreatic carcinoma1/3231 (0%)
Rectal cancer1/3231 (0%)
Thyroid cancer1/3231 (0%)
Uterine leiomyoma1/3231 (0%)
Nervous system disorders
Cerebral infarction1/3231 (0%)
Headache1/3231 (0%)
Intracranial aneurysm1/3231 (0%)
Renal and urinary disorders
Acute kidney injury1/3231 (0%)
Ureterolithiasis1/3231 (0%)
Reproductive system and breast disorders
Cervix inflammation1/3231 (0%)
Skin and subcutaneous tissue disorders
Diabetic foot1/3231 (0%)
Vascular disorders
Deep vein thrombosis1/3231 (0%)
Other (Not Including Serious) Adverse Events
JARDIANCE®
Affected / at Risk (%)# Events
Total0/3231 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleBoehringer Ingelheim, Call Center
OrganizationBoehringer Ingelheim
Phone1-800-243-0127
Emailclintriage.rdg@boehringer-ingelheim.com
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02848833
Other Study ID Numbers:
  • 1245.116
First Posted:
Jul 29, 2016
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021