Empagliflozin (BI 10773) Dose Finder Study in Japanese Pa... | NCT01193218 | Trialant
NCT01193218
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jun 17, 2014Estimated
Enrollment
547Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
Placebo (low dose)
Placebo (low dose)
Placebo (mid dose)
Placebo (high dose)
BI 10773
Placebo (mid dose)
Placebo (high dose)
Placebo (high dose)
BI 10773
BI 10773
Placebo (mid dose)
Placebo (high dose)
Placebo (low dose)
Placebo (low dose)
BI 10773
Placebo (mid dose)
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01193218
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1245.38
Secondary IDs
Not provided
Brief Title
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Official Title
A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
May 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2010
Primary Completion Date
Jun 2012Actual
Completion Date
Jun 2012Actual
First Submitted Date
Aug 31, 2010
First Submission Date that Met QC Criteria
Aug 31, 2010
First Posted Date
Sep 1, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
May 16, 2014
Results First Submitted that Met QC Criteria
May 16, 2014
Results First Posted Date
Jun 17, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 16, 2014
Last Update Posted Date
Jun 17, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Name
Class
Eli Lilly and Company
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
547Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BI 10773 low dose QD
Experimental
BI 10773 tablets low dose once a day
Drug: Placebo (mid dose)
Drug: Placebo (high dose)
Drug: BI 10773
BI 10773 mid-low dose QD
Experimental
BI 10773 tablets mid-low dose once a day
Drug: Placebo (high dose)
Drug: Placebo (low dose)
Drug: BI 10773
BI 10773 mid-high dose QD
Experimental
BI 10773 tablets mid-high dose once a day
Drug: BI 10773
Drug: Placebo (high dose)
Drug: Placebo (low dose)
Drug: Placebo (mid dose)
BI 10773 high dose QD
Experimental
BI 10773 tablets high dose once a day
Drug: Placebo (low dose)
Drug: Placebo (mid dose)
Drug: BI 10773
Placebo
Placebo Comparator
Placebo tablets once a day
Drug: Placebo (low dose)
Drug: Placebo (high dose)
Drug: Placebo (mid dose)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo (low dose)
Drug
Placebo tablets once a day
Placebo
Placebo (low dose)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in HbA1c After 12 Weeks of Treatment.
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
baseline and 12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Occurrence of Treat to Target Efficacy Response
Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
baseline and 12 weeks
Change From Baseline in FPG
Other Outcomes
Measure
Description
Time Frame
Confirmed Hypoglycaemic Adverse Events
Number of patients with confirmed hypoglycaemic adverse events
between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are:
drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
HbA1c at Visit 1a:
for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%
HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)
Exclusion criteria:
Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1245.38.016 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
Japan
1245.38.001 Boehringer Ingelheim Investigational Site
It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
FG001
Placebo/Empa 25 mg
Periods
Title
Milestones
Reasons Not Completed
0-12 Weeks
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Not provided
Drug
Placebo tablets once a day
BI 10773 high dose QD
Placebo (mid dose)
Drug
Placebo tablets once a day
BI 10773 low dose QD
Placebo (high dose)
Drug
Placebo tablets once a day
BI 10773 low dose QD
BI 10773
Drug
BI 10773 tablets low dose once a day
BI 10773 low dose QD
Placebo (mid dose)
Drug
Placebo tablets once a day
BI 10773 high dose QD
Placebo (high dose)
Drug
Placebo tablets once a day
Placebo
Placebo (high dose)
Drug
Placebo tablets once a day
BI 10773 mid-low dose QD
BI 10773
Drug
BI 10773 tablets mid-high dose once a day
BI 10773 mid-high dose QD
BI 10773
Drug
BI 10773 tablets high dose once a day
BI 10773 high dose QD
Placebo (mid dose)
Drug
Placebo tablets once a day
Placebo
Placebo (high dose)
Drug
Placebo tablets once a day
BI 10773 mid-high dose QD
Placebo (low dose)
Drug
Placebo tablets once a day
BI 10773 mid-low dose QD
Placebo (low dose)
Drug
Placebo tablets once a day
BI 10773 mid-high dose QD
BI 10773
Drug
BI 10773 tablets mid-low dose once a day
BI 10773 mid-low dose QD
Placebo (mid dose)
Drug
Placebo tablets once a day
BI 10773 mid-high dose QD
Change from baseline in FPG after 12 weeks of treatment
baseline and 12 weeks
Chuo-ku, Tokyo
Japan
1245.38.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Japan
1245.38.002 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo
Japan
1245.38.010 Boehringer Ingelheim Investigational Site
Hanamaki, Iwate
Japan
1245.38.005 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
Japan
1245.38.020 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa
Japan
1245.38.013 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba
Japan
1245.38.019 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo
Japan
1245.38.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
Japan
1245.38.024 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime
Japan
1245.38.004 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo
Japan
1245.38.011 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
Japan
1245.38.030 Boehringer Ingelheim Investigational Site
Naha, Okinawa
Japan
1245.38.032 Boehringer Ingelheim Investigational Site
Okawa, Fukuoka
Japan
1245.38.031 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
Japan
1245.38.025 Boehringer Ingelheim Investigational Site
Saga, Saga
Japan
1245.38.014 Boehringer Ingelheim Investigational Site
Saitama, Saitama
Japan
1245.38.006 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1245.38.007 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1245.38.008 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1245.38.009 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1245.38.012 Boehringer Ingelheim Investigational Site
Sasima-gun, Ibaraki
Japan
1245.38.015 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
Japan
1245.38.018 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
Japan
1245.38.017 Boehringer Ingelheim Investigational Site
Suginami-ku, Tokyo
Japan
1245.38.022 Boehringer Ingelheim Investigational Site
Suita, Osaka
Japan
1245.38.023 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi
Japan
1245.38.026 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
Japan
1245.38.027 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
Japan
1245.38.028 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
Japan
1245.38.029 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
Japan
Derived
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
FG002
Empa 5mg/10mg
It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
FG003
Empa 5 mg/25 mg
It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
FG004
Empa 10mg
Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
FG005
Empa 25mg
Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
FG006
Empa 50mg\10mg
It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
FG007
Empa 50 mg/25 mg
It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
FG000109 subjectsIt is actually placebo group
FG0010 subjectsIt is actually N/A
FG002110 subjectsIt is actually empa 5mg group
FG0030 subjectsIt is actually N/A
FG004109 subjects
FG005109 subjects
FG006110 subjectsIt is actually empa 50mg group
FG0070 subjectsIt is actually N/A
COMPLETED
FG000100 subjects
FG0010 subjects
FG002107 subjects
FG0030 subjects
FG004108 subjects
FG005106 subjects
FG006107 subjects
FG0070 subjects
NOT COMPLETED
FG0009 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0063 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
FG0070 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
12-52 Weeks
Type
Comment
Milestone Data
STARTED
FG00050 subjects
FG00150 subjects
FG00254 subjects
FG00353 subjects
FG004108 subjects
FG005106 subjects
FG00654 subjects
FG00753 subjects
COMPLETED
FG00045 subjects
FG00150 subjects
FG00250 subjects
FG00350 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0010 subjects
FG0024 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (12 Week)
Placebo once daily group in the 12-week first treatment period
BG001
Empa 5mg (12 Week)
Empagliflozin 5 mg once daily group in the 12-week first treatment period
BG002
Empa 10mg (12 Week)
Empagliflozin 10 mg once daily group in the 12-week first treatment period
BG003
Empa 25mg (12 Week)
Empagliflozin 25 mg once daily group in the 12-week first treatment period
BG004
Empa 50mg (12 Week)
Empagliflozin 50 mg once daily group in the 12-week first treatment period
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000109
BG001110
BG002109
BG003109
BG004110
BG005547
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.7± 8.7
BG00157.3± 11.2
BG00257.9± 9.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00126
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in HbA1c After 12 Weeks of Treatment.
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Full analysis set (FAS)
Posted
Least Squares Mean
Standard Error
percentage of HbA1c
baseline and 12 weeks
ID
Title
Description
OG000
Placebo (12 Week)
Placebo once daily group in the 12-week first treatment period
OG001
Empa 5mg (12 Week)
Empagliflozin 5 mg once daily group in the 12-week first treatment period
OG002
Empa 10mg (12 Week)
Empagliflozin 10 mg once daily group in the 12-week first treatment period
OG003
Empa 25mg (12 Week)
Empagliflozin 25 mg once daily group in the 12-week first treatment period
OG004
Empa 50mg (12 Week)
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Units
Counts
Participants
OG000109
OG001110
OG002109
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.30± 0.09
OG001-0.42± 0.09
OG002-0.40± 0.09
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference calculated as empa 5mg minus placebo
ANCOVA
'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
<0.0001
the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Mean Difference (Final Values)
-0.72
Standard Error of the Mean
0.08
2-Sided
95
-0.87
-0.57
No
Superiority or Other
Secondary
Occurrence of Treat to Target Efficacy Response
Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
Full analysis set (FAS)
Posted
Number
95% Confidence Interval
percentage of participants
baseline and 12 weeks
ID
Title
Description
OG000
Placebo (12 Week)
Placebo once daily group in the 12-week first treatment period
OG001
Empa 5mg (12 Week)
Empagliflozin 5 mg once daily group in the 12-week first treatment period
OG002
Empa 10mg (12 Week)
Empagliflozin 10 mg once daily group in the 12-week first treatment period
OG003
Empa 25mg (12 Week)
Empagliflozin 25 mg once daily group in the 12-week first treatment period
OG004
Empa 50mg (12 Week)
Secondary
Change From Baseline in FPG
Change from baseline in FPG after 12 weeks of treatment
Full analysis set (FAS)
Posted
Least Squares Mean
Standard Error
mg/dL
baseline and 12 weeks
ID
Title
Description
OG000
Placebo (12 Week)
Placebo once daily group in the 12-week first treatment period
OG001
Empa 5mg (12 Week)
Empagliflozin 5 mg once daily group in the 12-week first treatment period
OG002
Empa 10mg (12 Week)
Empagliflozin 10 mg once daily group in the 12-week first treatment period
OG003
Empa 25mg (12 Week)
Empagliflozin 25 mg once daily group in the 12-week first treatment period
OG004
Empa 50mg (12 Week)
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Other Pre-specified
Confirmed Hypoglycaemic Adverse Events
Number of patients with confirmed hypoglycaemic adverse events
Treated patients
Posted
Number
participants
between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
ID
Title
Description
OG000
Placebo (12 Week)
Placebo once daily group in the 12-week first treatment period
OG001
Empa 5mg (12 Week)
Empagliflozin 5 mg once daily group in the 12-week first treatment period
OG002
Empa 10mg (12 Week)
Empagliflozin 10 mg once daily group in the 12-week first treatment period
OG003
Empa 25mg (12 Week)
Empagliflozin 25 mg once daily group in the 12-week first treatment period
OG004
Empa 50mg (12 Week)
Time Frame
between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (12 Week)
Placebo once daily group in the 12-week first treatment period
3
109
15
109
EG001
Empa 5mg (12 Week)
Empagliflozin 5 mg once daily group in the 12-week first treatment period
0
110
19
110
EG002
Empa 10mg (12 Week)
Empagliflozin 10 mg once daily group in the 12-week first treatment period
0
109
16
109
EG003
Empa 25mg (12 Week)
Empagliflozin 25 mg once daily group in the 12-week first treatment period
3
109
26
109
EG004
Empa 50mg (12 Week)
Empagliflozin 50 mg once daily group in the 12-week first treatment period
1
110
20
110
EG005
Empa 10mg (Randomized, 52 Week)
Patients randomized to empagliflozin 10mg once daily for 52 weeks
3
109
39
109
EG006
Empa 25mg (Randomized, 52 Week)
Patients randomized to empagliflozin 25 mg once daily for 52 weeks
8
109
49
109
EG007
Empa 10mg (With at Least One Dose, 52 Week)
Patients with at least one dose of empagliflozin 10 mg once daily for 52-week treatment
8
267
83
267
EG008
Empa 25mg (With at Least One Dose, 52 Week)
Patients with at least one dose of empagliflozin 25 mg once daily for 52-week treatment
15
265
93
265
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pharyngitis
Infections and infestations
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG0031 affected109 at risk
EG0040 affected110 at risk
EG0050 affected109 at risk
EG0061 affected109 at risk
EG0070 affected267 at risk
EG0081 affected265 at risk
Tonsillitis
Infections and infestations
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Viral infection
Infections and infestations
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Metastases to bone marrow
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Cerebral infarction
Nervous system disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Glaucoma
Eye disorders
MEDDRA 15.0
Systematic Assessment
EG0001 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Macular hole
Eye disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MEDDRA 15.0
Systematic Assessment
EG0001 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Myocardial infarction
Cardiac disorders
MEDDRA 15.0
Systematic Assessment
EG0001 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Device dislocation
General disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Pyrexia
General disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Carbohydrate antigen 19-9 increased
Investigations
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Prostatic specific antigen increased
Investigations
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0010 affected110 at risk
EG0020 affected109 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MEDDRA 15.0
Systematic Assessment
EG00010 affected109 at risk
EG0018 affected110 at risk
EG0029 affected109 at risk
EG00311 affected109 at risk
EG00411 affected110 at risk
EG00530 affected109 at risk
EG00633 affected109 at risk
EG00762 affected267 at risk
EG00863 affected265 at risk
Pharyngitis
Infections and infestations
MEDDRA 15.0
Systematic Assessment
EG0001 affected109 at risk
EG0010 affected110 at risk
EG0024 affected109 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 15.0
Systematic Assessment
EG0003 affected109 at risk
EG0012 affected110 at risk
EG0020 affected109 at risk
EG003
Dental caries
Gastrointestinal disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0011 affected110 at risk
EG0021 affected109 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.0
Systematic Assessment
EG0000 affected109 at risk
EG0014 affected110 at risk
EG0021 affected109 at risk
EG003
Pollakiuria
Renal and urinary disorders
MEDDRA 15.0
Systematic Assessment
EG0001 affected109 at risk
EG0014 affected110 at risk
EG0021 affected109 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C570240
empagliflozin
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
104 subjects
FG005101 subjects
FG00651 subjects
FG00749 subjects
4 subjects
FG0055 subjects
FG0063 subjects
FG0074 subjects
2 subjects
FG0043 subjects
FG0053 subjects
FG0061 subjects
FG0072 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
FG0072 subjects
Other reason than above
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
57.2
± 9.7
BG00456.6± 10.3
BG00557.5± 9.9
32
BG00325
BG00425
BG005137
Male
BG00080
BG00184
BG00277
BG00384
BG00485
BG005410
109
OG004110
-0.65
± 0.09
OG004-0.61± 0.09
OG000
OG002
Difference calculated as empa 10mg minus placebo
ANCOVA
'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
<0.0001
the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Mean Difference (Final Values)
-0.70
Standard Error of the Mean
0.08
2-Sided
95
-0.85
-0.55
No
Superiority or Other
OG000
OG003
Difference calculated as empa 25mg minus placebo
ANCOVA
'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
<0.0001
the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Mean Difference (Final Values)
-0.95
Standard Error of the Mean
0.08
2-Sided
95
-1.10
-0.80
No
Superiority or Other
OG000
OG004
Difference calculated as empa 50mg minus placebo
ANCOVA
'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate
<0.0001
the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Mean Difference (Final Values)
-0.91
Standard Error of the Mean
0.08
2-Sided
95
-1.06
-0.76
No
Superiority or Other
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Units
Counts
Participants
OG000106
OG001107
OG002105
OG003106
OG004107
Title
Denominators
Categories
Title
Measurements
OG0002.8(0.6 to 8.0)
OG00126.2(18.1 to 35.6)
OG00219.0(12.0 to 27.9)
OG00332.1(23.3 to 41.8)
OG00432.7(24.0 to 42.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo
Regression, Logistic
The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.
<0.0001
Odds Ratio (OR)
19.367
2-Sided
95
5.340
70.236
No
Superiority or Other
OG000
OG002
Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo
Regression, Logistic
The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.
0.0003
Odds Ratio (OR)
10.889
2-Sided
95
2.942
40.301
No
Superiority or Other
OG000
OG003
Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo
Regression, Logistic
The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.
<0.0001
Odds Ratio (OR)
27.624
2-Sided
95
7.601
99.99
The upper limit of confidence interval is actually >99.99
No
Superiority or Other
OG000
OG004
Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo
Regression, Logistic
The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.
<0.0001
Odds Ratio (OR)
44.906
2-Sided
95
12.120
99.99
The upper limit of confidence interval is actually >99.99
No
Superiority or Other
Units
Counts
Participants
OG000109
OG001110
OG002109
OG003109
OG004110
Title
Denominators
Categories
Title
Measurements
OG0004.06± 2.88
OG001-22.65± 2.97
OG002-25.28± 2.77
OG003-33.70± 2.92
OG004-32.54± 2.97
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference calculated as empa 5mg minus placebo
ANCOVA
treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
<0.0001
Mean Difference (Final Values)
-26.70
Standard Error of the Mean
2.50
2-Sided
95
-31.61
-21.80
No
Superiority or Other
OG000
OG002
Difference calculated as empa 10mg minus placebo
ANCOVA
treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
<0.0001
Mean Difference (Final Values)
-29.34
Standard Error of the Mean
2.50
2-Sided
95
-34.25
-24.42
No
Superiority or Other
OG000
OG003
Difference calculated as empa 25mg minus placebo
ANCOVA
treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
<0.0001
Mean Difference (Final Values)
-37.75
Standard Error of the Mean
2.50
2-Sided
95
-42.66
-32.84
No
Superiority or Other
OG000
OG004
Difference calculated as empa 50mg minus placebo
ANCOVA
treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
<0.0001
Mean Difference (Final Values)
-36.60
Standard Error of the Mean
2.50
2-Sided
95
-41.51
-31.69
No
Superiority or Other
Empagliflozin 50 mg once daily group in the 12-week first treatment period