Empagliflozin (BI 10773) Comprehensive add-on Study in Ja... | NCT01368081 | Trialant
NCT01368081
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jun 17, 2014Estimated
Enrollment
1,162Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
Metformin
BI 10773
Placebo (low dose)
BI 10773
Placebo (high dose)
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01368081
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1245.52
Secondary IDs
Not provided
Brief Title
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Official Title
A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
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
May 2011
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
First Submitted Date
May 19, 2011
First Submission Date that Met QC Criteria
Jun 6, 2011
First Posted Date
Jun 7, 2011Estimated
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
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,162Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BI 10773 low dose
Experimental
BI 10773 low dose tablet once daily
Drug: BI 10773
Drug: Placebo (high dose)
BI 10773 high dose
Experimental
BI 10773 high dose tablet once daily
Drug: Placebo (low dose)
Drug: BI 10773
Metformin
Active Comparator
Metformin tablets 500-2250 mg a day (twice or three times per day)
Drug: Metformin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Metformin
Drug
Metformin tablets 500-2250 mg a day (twice or three times per day)
Metformin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Patients With Drug Related Adverse Events
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
After the first drug intake until 7 days after the last treatment administration, up to 383 days
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in HbA1c
Change from baseline in HbA1c after 52 weeks of treatment
Baseline and 52 weeks
Other Outcomes
Measure
Description
Time Frame
Confirmed Hypoglycaemic Adverse Events
Number of patients with confirmed hypoglycaemic adverse events
After the first drug intake until 7 days after the last treatment administration, up to 383 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 pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)
Exclusion criteria:
Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
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
1245.52.023 Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo
Japan
1245.52.048 Boehringer Ingelheim Investigational Site
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.
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
FG001
Sulfonylurea: Empa 25mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
BI 10773
Drug
BI 10773 low dose tablet once daily
BI 10773 low dose
Placebo (low dose)
Drug
Placebo tablets once daily
BI 10773 high dose
BI 10773
Drug
BI 10773 high dose tablet once daily
BI 10773 high dose
Placebo (high dose)
Drug
Placebo tablets once daily
BI 10773 low dose
Aki-gun, Hiroshima
Japan
1245.52.012 Boehringer Ingelheim Investigational Site
Annaka, Gunma
Japan
1245.52.087 Boehringer Ingelheim Investigational Site
Atami, Shizuoka
Japan
1245.52.008 Boehringer Ingelheim Investigational Site
Beppu, Oita
Japan
1245.52.073 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
Japan
1245.52.002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Japan
1245.52.020 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Japan
1245.52.021 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Japan
1245.52.031 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa
Japan
1245.52.077 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
Japan
1245.52.086 Boehringer Ingelheim Investigational Site
Hadano, Kanagawa
Japan
1245.52.037 Boehringer Ingelheim Investigational Site
Hamamatsu, Shizuoka
Japan
1245.52.046 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
Japan
1245.52.047 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
Japan
1245.52.051 Boehringer Ingelheim Investigational Site
Imabari, Ehime
Japan
1245.52.016 Boehringer Ingelheim Investigational Site
Iruma,Saitama
Japan
1245.52.033 Boehringer Ingelheim Investigational Site
Isehara, Kanagawa
Japan
1245.52.011 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
Japan
1245.52.045 Boehringer Ingelheim Investigational Site
Izumisano,Osaka
Japan
1245.52.088 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
Japan
1245.52.072 Boehringer Ingelheim Investigational Site
Kamakura,Kanagawa
Japan
1245.52.034 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa
Japan
1245.52.058 Boehringer Ingelheim Investigational Site
Kanoya, Kagoshima
Japan
1245.52.019 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba
Japan
1245.52.039 Boehringer Ingelheim Investigational Site
Kasugai, Aichi
Japan
1245.52.027 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa
Japan
1245.52.018 Boehringer Ingelheim Investigational Site
Kita-adachi-gun, Saitama
Japan
1245.52.022 Boehringer Ingelheim Investigational Site
Kita-ku, Tokyo
Japan
1245.52.052 Boehringer Ingelheim Investigational Site
Kitakyushu, Fukuoka
Japan
1245.52.076 Boehringer Ingelheim Investigational Site
Kobe, Hyogo
Japan
1245.52.026 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
Japan
1245.52.069 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
Japan
1245.52.071 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
Japan
1245.52.014 Boehringer Ingelheim Investigational Site
Koshigaya, Saitama
Japan
1245.52.074 Boehringer Ingelheim Investigational Site
Kuki, Saitama
Japan
1245.52.055 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto
Japan
1245.52.049 Boehringer Ingelheim Investigational Site
Kure, Hiroshima
Japan
1245.52.040 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
Japan
1245.52.010 Boehringer Ingelheim Investigational Site
Maebashi, Gunma
Japan
1245.52.080 Boehringer Ingelheim Investigational Site
Maebashi, Gunma
Japan
1245.52.050 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime
Japan
1245.52.075 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
Japan
1245.52.056 Boehringer Ingelheim Investigational Site
Miyazaki, Miyazaki
Japan
1245.52.057 Boehringer Ingelheim Investigational Site
Miyazaki, Miyazaki
Japan
1245.52.079 Boehringer Ingelheim Investigational Site
Morioka, Iwate
Japan
1245.52.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1245.52.004 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1245.52.005 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1245.52.038 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1245.52.059 Boehringer Ingelheim Investigational Site
Naha, Okinawa
Japan
1245.52.066 Boehringer Ingelheim Investigational Site
Naha, Okinawa
Japan
1245.52.065 Boehringer Ingelheim Investigational Site
Nanjyo, Okinawa
Japan
1245.52.007 Boehringer Ingelheim Investigational Site
Oita, Oita
Japan
1245.52.053 Boehringer Ingelheim Investigational Site
Okawa, Fukuoka
Japan
1245.52.068 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
Japan
1245.52.042 Boehringer Ingelheim Investigational Site
Osaka,Osaka
Japan
1245.52.089 Boehringer Ingelheim Investigational Site
Osaki, Miyagi
Japan
1245.52.024 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo
Japan
1245.52.054 Boehringer Ingelheim Investigational Site
Saga, Saga
Japan
1245.52.032 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
Japan
1245.52.085 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
Japan
1245.52.013 Boehringer Ingelheim Investigational Site
Saitama, Saitama
Japan
1245.52.015 Boehringer Ingelheim Investigational Site
Sakado, Saitama
Japan
1245.52.044 Boehringer Ingelheim Investigational Site
Sakai, Osaka
Japan
1245.52.035 Boehringer Ingelheim Investigational Site
Saku, Nagano
Japan
1245.52.009 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1245.52.025 Boehringer Ingelheim Investigational Site
Setagaya-ku, Tokyo
Japan
1245.52.063 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa
Japan
1245.52.064 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa
Japan
1245.52.001 Boehringer Ingelheim Investigational Site
Shinjuku-ku. Tokyo
Japan
1245.52.036 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka
Japan
1245.52.006 Boehringer Ingelheim Investigational Site
Suita, Osaka
Japan
1245.52.043 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
Japan
1245.52.017 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
Japan
1245.52.070 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
Japan
1245.52.061 Boehringer Ingelheim Investigational Site
Tomigusuku, Okinawa
Japan
1245.52.062 Boehringer Ingelheim Investigational Site
Tomigusuku, Okinawa
Japan
1245.52.041 Boehringer Ingelheim Investigational Site
Uji, Kyoto
Japan
1245.52.067 Boehringer Ingelheim Investigational Site
Uruma, Okinawa
Japan
1245.52.028 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
1245.52.029 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
1245.52.030 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
1245.52.081 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
1245.52.082 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
1245.52.083 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
1245.52.084 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
Derived
Araki E, Tanizawa Y, Tanaka Y, Taniguchi A, Koiwai K, Kim G, Salsali A, Woerle HJ, Broedl UC. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665-74. doi: 10.1111/dom.12464. Epub 2015 Apr 15.
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
FG002
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
FG003
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
FG004
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
FG005
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
FG006
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
FG007
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
FG008
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
FG009
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
FG010
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
FG011
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
FG012
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
FG000136 subjects
FG001137 subjects
FG00263 subjects
FG00368 subjects
FG00465 subjects
FG005137 subjects
FG006136 subjects
FG00769 subjects
FG00870 subjects
FG00968 subjects
FG01071 subjects
FG01170 subjects
FG01270 subjects
COMPLETED
FG000126 subjects
FG001128 subjects
FG00259 subjects
FG00363 subjects
FG00463 subjects
FG005127 subjects
FG006124 subjects
FG00762 subjects
FG00862 subjects
FG00958 subjects
FG01062 subjects
FG01167 subjects
FG01263 subjects
NOT COMPLETED
FG00010 subjects
FG0019 subjects
FG0024 subjects
FG0035 subjects
FG0042 subjects
FG00510 subjects
FG00612 subjects
FG0077 subjects
FG0088 subjects
FG00910 subjects
FG0109 subjects
FG0113 subjects
FG0127 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0032 subjects
FG0042 subjects
FG0055 subjects
FG0066 subjects
FG0072 subjects
FG0083 subjects
FG0095 subjects
FG0106 subjects
FG0111 subjects
FG0123 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Other reason not defined above
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
BG001
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
BG002
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
BG003
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
BG004
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
BG005
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
BG006
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
BG007
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
BG008
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
BG009
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
BG010
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
BG011
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
BG012
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000136
BG001137
BG00263
BG00368
BG00465
BG005137
BG006136
BG00769
BG00870
BG00968
BG01071
BG01170
BG01270
BG0131160
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
BG00061.3± 9.9
BG00161.8± 9.6
BG00260.0± 10.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00037
BG00141
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
Secondary
Change From Baseline in HbA1c
Change from baseline in HbA1c after 52 weeks of treatment
Full analysis set
Posted
Least Squares Mean
Standard Error
percentage of HbA1c
Baseline and 52 weeks
ID
Title
Description
OG000
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
OG001
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
OG002
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
OG003
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
OG004
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
OG005
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
OG006
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
OG007
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
OG008
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
OG009
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
OG010
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
OG011
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
OG012
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Units
Counts
Participants
OG000136
OG001137
OG00263
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.93± 0.05
OG001-0.96± 0.05
OG002-0.97± 0.08
OG003
Primary
Number of Patients With Drug Related Adverse Events
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Treated patients
Posted
Number
participants
After the first drug intake until 7 days after the last treatment administration, up to 383 days
ID
Title
Description
OG000
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
OG001
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
OG002
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
OG003
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
Other Pre-specified
Confirmed Hypoglycaemic Adverse Events
Number of patients with confirmed hypoglycaemic adverse events
Treated patients
Posted
Number
participants
After the first drug intake until 7 days after the last treatment administration, up to 383 days
ID
Title
Description
OG000
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
OG001
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
OG002
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
OG003
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
Time Frame
After the first drug intake until 7 days after the last treatment administration, up to 383 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
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
10
136
73
136
EG001
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
7
137
74
137
EG002
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
3
63
44
63
EG003
Biguanide: Empa 10mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
7
68
32
68
EG004
Biguanide: Empa 25mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
2
65
35
65
EG005
Thiazolidinedione: Empa 10mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
12
137
77
137
EG006
Thiazolidinedione: Empa 25mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
12
136
74
136
EG007
Alpha-GI: Empa 10mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
2
69
40
69
EG008
Alpha-GI: Empa 25mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
5
70
34
70
EG009
DPP-4 Inhibitor: Empa 10mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
7
68
37
68
EG010
DPP-4 Inhibitor: Empa 25mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
5
71
36
71
EG011
Glinide: Empa 10mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
1
70
30
70
EG012
Glinide: Empa 25mg
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
4
70
38
70
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urinary tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG0031 affected68 at risk
EG0040 affected65 at risk
EG0050 affected137 at risk
EG0060 affected136 at risk
EG0070 affected69 at risk
EG0080 affected70 at risk
EG0090 affected68 at risk
EG0100 affected71 at risk
EG0110 affected70 at risk
EG0120 affected70 at risk
Cellulitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Febrile infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Gangrene
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Osteomyelitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Pyelonephritis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0021 affected63 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0021 affected63 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0021 affected63 at risk
EG003
Benign ovarian tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Oropharyngeal cancer stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Small cell lung cancer stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Anaphylactic reaction
Immune system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Schizophrenia
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Lacunar infarction
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Cerebral arteriosclerosis
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Cerebral infarction
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Cataract
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0012 affected137 at risk
EG0020 affected63 at risk
EG003
Glaucoma
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Retinal detachment
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Congestive cardiomyopathy
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Myocardial infarction
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Prinzmetal angina
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Angina pectoris
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Atrial fibrillation
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Embolism arterial
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Artery dissection
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Anal fissure
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Duodenitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Leukoplakia oral
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Megacolon
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Melaena
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Bladder prolapse
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected137 at risk
EG0020 affected63 at risk
EG003
Heat illness
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG00041 affected136 at risk
EG00138 affected137 at risk
EG00226 affected63 at risk
EG00312 affected68 at risk
EG00423 affected65 at risk
EG00544 affected137 at risk
EG00637 affected136 at risk
EG00726 affected69 at risk
EG00821 affected70 at risk
EG00923 affected68 at risk
EG01015 affected71 at risk
EG01116 affected70 at risk
EG01217 affected70 at risk
Influenza
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0012 affected137 at risk
EG0025 affected63 at risk
EG003
Pharyngitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0003 affected136 at risk
EG0017 affected137 at risk
EG0022 affected63 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected136 at risk
EG0014 affected137 at risk
EG0022 affected63 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0007 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG00011 affected136 at risk
EG00112 affected137 at risk
EG0026 affected63 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected136 at risk
EG0012 affected137 at risk
EG0022 affected63 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0007 affected136 at risk
EG0016 affected137 at risk
EG0024 affected63 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0005 affected136 at risk
EG0015 affected137 at risk
EG0022 affected63 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected136 at risk
EG0012 affected137 at risk
EG0025 affected63 at risk
EG003
Gastritis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0003 affected136 at risk
EG0012 affected137 at risk
EG0022 affected63 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0003 affected136 at risk
EG0017 affected137 at risk
EG0021 affected63 at risk
EG003
Pollakiuria
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0003 affected136 at risk
EG0016 affected137 at risk
EG0020 affected63 at risk
EG003
Thirst
General disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected136 at risk
EG0010 affected137 at risk
EG0020 affected63 at risk
EG003
Fall
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0004 affected136 at risk
EG0016 affected137 at risk
EG0025 affected63 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0002 affected136 at risk
EG0013 affected137 at risk
EG0024 affected63 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
D008687
Metformin
C570240
empagliflozin
Ancestor Terms
ID
Term
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
0 subjects
FG0053 subjects
FG0064 subjects
FG0072 subjects
FG0085 subjects
FG0094 subjects
FG0103 subjects
FG0112 subjects
FG0120 subjects
0 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0123 subjects
56.9
± 9.5
BG00457.3± 11.4
BG00560.4± 10.1
BG00659.7± 9.9
BG00763.5± 8.8
BG00861.9± 11.7
BG00963.3± 9.9
BG01059.1± 10.3
BG01159.2± 12.1
BG01257.7± 11.8
BG01360.3± 10.4
16
BG00330
BG00422
BG00523
BG00634
BG00718
BG00818
BG00927
BG01023
BG01123
BG01213
BG013325
Male
BG00099
BG00196
BG00247
BG00338
BG00443
BG005114
BG006102
BG00751
BG00852
BG00941
BG01048
BG01147
BG01257
BG013835
68
OG00465
OG005137
OG006136
OG00769
OG00870
OG00968
OG01071
OG01170
OG01270
-0.81
± 0.06
OG004-0.98± 0.06
OG005-0.90± 0.05
OG006-0.96± 0.05
OG007-0.87± 0.06
OG008-0.77± 0.06
OG009-1.00± 0.06
OG010-0.83± 0.06
OG011-0.98± 0.08
OG012-0.98± 0.08
OG004
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
OG005
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
OG006
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
OG007
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
OG008
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
OG009
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
OG010
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
OG011
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
OG012
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Units
Counts
Participants
OG000136
OG001137
OG00263
OG00368
OG00465
OG005137
OG006136
OG00769
OG00870
OG00968
OG01071
OG01170
OG01270
Title
Denominators
Categories
Title
Measurements
OG00019
OG00125
OG00213
OG00313
OG0049
OG00520
OG00619
OG0077
OG0085
OG0099
OG01018
OG0119
OG0129
OG004
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
OG005
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
OG006
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
OG007
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
OG008
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
OG009
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
OG010
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
OG011
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
OG012
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide