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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Metformin
BI 10773
Placebo (low dose)
BI 10773
Placebo (high dose)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • 1245.52.023 Boehringer Ingelheim Investigational Site
  • 1245.52.048 Boehringer Ingelheim Investigational Site
  • 1245.52.012 Boehringer Ingelheim Investigational Site
  • 1245.52.087 Boehringer Ingelheim Investigational Site
  • 1245.52.008 Boehringer Ingelheim Investigational Site
  • 1245.52.073 Boehringer Ingelheim Investigational Site
  • 1245.52.002 Boehringer Ingelheim Investigational Site
  • 1245.52.020 Boehringer Ingelheim Investigational Site
  • 1245.52.021 Boehringer Ingelheim Investigational Site
  • 1245.52.031 Boehringer Ingelheim Investigational Site
  • 1245.52.077 Boehringer Ingelheim Investigational Site
  • 1245.52.086 Boehringer Ingelheim Investigational Site
  • 1245.52.037 Boehringer Ingelheim Investigational Site
  • 1245.52.046 Boehringer Ingelheim Investigational Site
  • 1245.52.047 Boehringer Ingelheim Investigational Site
  • 1245.52.051 Boehringer Ingelheim Investigational Site
  • 1245.52.016 Boehringer Ingelheim Investigational Site
  • 1245.52.033 Boehringer Ingelheim Investigational Site
  • 1245.52.011 Boehringer Ingelheim Investigational Site
  • 1245.52.045 Boehringer Ingelheim Investigational Site
  • 1245.52.088 Boehringer Ingelheim Investigational Site
  • 1245.52.072 Boehringer Ingelheim Investigational Site
  • 1245.52.034 Boehringer Ingelheim Investigational Site
  • 1245.52.058 Boehringer Ingelheim Investigational Site
  • 1245.52.019 Boehringer Ingelheim Investigational Site
  • 1245.52.039 Boehringer Ingelheim Investigational Site
  • 1245.52.027 Boehringer Ingelheim Investigational Site
  • 1245.52.018 Boehringer Ingelheim Investigational Site
  • 1245.52.022 Boehringer Ingelheim Investigational Site
  • 1245.52.052 Boehringer Ingelheim Investigational Site
  • 1245.52.076 Boehringer Ingelheim Investigational Site
  • 1245.52.026 Boehringer Ingelheim Investigational Site
  • 1245.52.069 Boehringer Ingelheim Investigational Site
  • 1245.52.071 Boehringer Ingelheim Investigational Site
  • 1245.52.014 Boehringer Ingelheim Investigational Site
  • 1245.52.074 Boehringer Ingelheim Investigational Site
  • 1245.52.055 Boehringer Ingelheim Investigational Site
  • 1245.52.049 Boehringer Ingelheim Investigational Site
  • 1245.52.040 Boehringer Ingelheim Investigational Site
  • 1245.52.010 Boehringer Ingelheim Investigational Site
  • 1245.52.080 Boehringer Ingelheim Investigational Site
  • 1245.52.050 Boehringer Ingelheim Investigational Site
  • 1245.52.075 Boehringer Ingelheim Investigational Site
  • 1245.52.056 Boehringer Ingelheim Investigational Site
  • 1245.52.057 Boehringer Ingelheim Investigational Site
  • 1245.52.079 Boehringer Ingelheim Investigational Site
  • 1245.52.003 Boehringer Ingelheim Investigational Site
  • 1245.52.004 Boehringer Ingelheim Investigational Site
  • 1245.52.005 Boehringer Ingelheim Investigational Site
  • 1245.52.038 Boehringer Ingelheim Investigational Site
  • 1245.52.059 Boehringer Ingelheim Investigational Site
  • 1245.52.066 Boehringer Ingelheim Investigational Site
  • 1245.52.065 Boehringer Ingelheim Investigational Site
  • 1245.52.007 Boehringer Ingelheim Investigational Site
  • 1245.52.053 Boehringer Ingelheim Investigational Site
  • 1245.52.068 Boehringer Ingelheim Investigational Site
  • 1245.52.042 Boehringer Ingelheim Investigational Site
  • 1245.52.089 Boehringer Ingelheim Investigational Site
  • 1245.52.024 Boehringer Ingelheim Investigational Site
  • 1245.52.054 Boehringer Ingelheim Investigational Site
  • 1245.52.032 Boehringer Ingelheim Investigational Site
  • 1245.52.085 Boehringer Ingelheim Investigational Site
  • 1245.52.013 Boehringer Ingelheim Investigational Site
  • 1245.52.015 Boehringer Ingelheim Investigational Site
  • 1245.52.044 Boehringer Ingelheim Investigational Site
  • 1245.52.035 Boehringer Ingelheim Investigational Site
  • 1245.52.009 Boehringer Ingelheim Investigational Site
  • 1245.52.025 Boehringer Ingelheim Investigational Site
  • 1245.52.063 Boehringer Ingelheim Investigational Site
  • 1245.52.064 Boehringer Ingelheim Investigational Site
  • 1245.52.001 Boehringer Ingelheim Investigational Site
  • 1245.52.036 Boehringer Ingelheim Investigational Site
  • 1245.52.006 Boehringer Ingelheim Investigational Site
  • 1245.52.043 Boehringer Ingelheim Investigational Site
  • 1245.52.017 Boehringer Ingelheim Investigational Site
  • 1245.52.070 Boehringer Ingelheim Investigational Site
  • 1245.52.061 Boehringer Ingelheim Investigational Site
  • 1245.52.062 Boehringer Ingelheim Investigational Site
  • 1245.52.041 Boehringer Ingelheim Investigational Site
  • 1245.52.067 Boehringer Ingelheim Investigational Site
  • 1245.52.028 Boehringer Ingelheim Investigational Site
  • 1245.52.029 Boehringer Ingelheim Investigational Site
  • 1245.52.030 Boehringer Ingelheim Investigational Site
  • 1245.52.081 Boehringer Ingelheim Investigational Site
  • 1245.52.082 Boehringer Ingelheim Investigational Site
  • 1245.52.083 Boehringer Ingelheim Investigational Site
  • 1245.52.084 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BI 10773 low dose

BI 10773 high dose

Metformin

Arm Description

BI 10773 low dose tablet once daily

BI 10773 high dose tablet once daily

Metformin tablets 500-2250 mg a day (twice or three times per day)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in HbA1c
Change from baseline in HbA1c after 52 weeks of treatment

Full Information

First Posted
May 19, 2011
Last Updated
May 16, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01368081
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 low dose
Arm Type
Experimental
Arm Description
BI 10773 low dose tablet once daily
Arm Title
BI 10773 high dose
Arm Type
Experimental
Arm Description
BI 10773 high dose tablet once daily
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin tablets 500-2250 mg a day (twice or three times per day)
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin tablets 500-2250 mg a day (twice or three times per day)
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 low dose tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo (low dose)
Intervention Description
Placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 high dose tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo (high dose)
Intervention Description
Placebo tablets once daily
Primary Outcome Measure Information:
Title
Number of Patients With Drug Related Adverse Events
Description
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
Time Frame
After the first drug intake until 7 days after the last treatment administration, up to 383 days
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c
Description
Change from baseline in HbA1c after 52 weeks of treatment
Time Frame
Baseline and 52 weeks
Other Pre-specified Outcome Measures:
Title
Confirmed Hypoglycaemic Adverse Events
Description
Number of patients with confirmed hypoglycaemic adverse events
Time Frame
After the first drug intake until 7 days after the last treatment administration, up to 383 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1245.52.023 Boehringer Ingelheim Investigational Site
City
Adachi-ku, Tokyo
Country
Japan
Facility Name
1245.52.048 Boehringer Ingelheim Investigational Site
City
Aki-gun, Hiroshima
Country
Japan
Facility Name
1245.52.012 Boehringer Ingelheim Investigational Site
City
Annaka, Gunma
Country
Japan
Facility Name
1245.52.087 Boehringer Ingelheim Investigational Site
City
Atami, Shizuoka
Country
Japan
Facility Name
1245.52.008 Boehringer Ingelheim Investigational Site
City
Beppu, Oita
Country
Japan
Facility Name
1245.52.073 Boehringer Ingelheim Investigational Site
City
Chiyoda-ku, Tokyo
Country
Japan
Facility Name
1245.52.002 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.52.020 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.52.021 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.52.031 Boehringer Ingelheim Investigational Site
City
Fujisawa, Kanagawa
Country
Japan
Facility Name
1245.52.077 Boehringer Ingelheim Investigational Site
City
Fukuoka, Fukuoka
Country
Japan
Facility Name
1245.52.086 Boehringer Ingelheim Investigational Site
City
Hadano, Kanagawa
Country
Japan
Facility Name
1245.52.037 Boehringer Ingelheim Investigational Site
City
Hamamatsu, Shizuoka
Country
Japan
Facility Name
1245.52.046 Boehringer Ingelheim Investigational Site
City
Himeji, Hyogo
Country
Japan
Facility Name
1245.52.047 Boehringer Ingelheim Investigational Site
City
Hiroshima, Hiroshima
Country
Japan
Facility Name
1245.52.051 Boehringer Ingelheim Investigational Site
City
Imabari, Ehime
Country
Japan
Facility Name
1245.52.016 Boehringer Ingelheim Investigational Site
City
Iruma,Saitama
Country
Japan
Facility Name
1245.52.033 Boehringer Ingelheim Investigational Site
City
Isehara, Kanagawa
Country
Japan
Facility Name
1245.52.011 Boehringer Ingelheim Investigational Site
City
Isesaki, Gunma
Country
Japan
Facility Name
1245.52.045 Boehringer Ingelheim Investigational Site
City
Izumisano,Osaka
Country
Japan
Facility Name
1245.52.088 Boehringer Ingelheim Investigational Site
City
Kamakura, Kanagawa
Country
Japan
Facility Name
1245.52.072 Boehringer Ingelheim Investigational Site
City
Kamakura,Kanagawa
Country
Japan
Facility Name
1245.52.034 Boehringer Ingelheim Investigational Site
City
Kanazawa, Ishikawa
Country
Japan
Facility Name
1245.52.058 Boehringer Ingelheim Investigational Site
City
Kanoya, Kagoshima
Country
Japan
Facility Name
1245.52.019 Boehringer Ingelheim Investigational Site
City
Kashiwa, Chiba
Country
Japan
Facility Name
1245.52.039 Boehringer Ingelheim Investigational Site
City
Kasugai, Aichi
Country
Japan
Facility Name
1245.52.027 Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
Country
Japan
Facility Name
1245.52.018 Boehringer Ingelheim Investigational Site
City
Kita-adachi-gun, Saitama
Country
Japan
Facility Name
1245.52.022 Boehringer Ingelheim Investigational Site
City
Kita-ku, Tokyo
Country
Japan
Facility Name
1245.52.052 Boehringer Ingelheim Investigational Site
City
Kitakyushu, Fukuoka
Country
Japan
Facility Name
1245.52.076 Boehringer Ingelheim Investigational Site
City
Kobe, Hyogo
Country
Japan
Facility Name
1245.52.026 Boehringer Ingelheim Investigational Site
City
Kodaira, Tokyo
Country
Japan
Facility Name
1245.52.069 Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
Country
Japan
Facility Name
1245.52.071 Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
Country
Japan
Facility Name
1245.52.014 Boehringer Ingelheim Investigational Site
City
Koshigaya, Saitama
Country
Japan
Facility Name
1245.52.074 Boehringer Ingelheim Investigational Site
City
Kuki, Saitama
Country
Japan
Facility Name
1245.52.055 Boehringer Ingelheim Investigational Site
City
Kumamoto, Kumamoto
Country
Japan
Facility Name
1245.52.049 Boehringer Ingelheim Investigational Site
City
Kure, Hiroshima
Country
Japan
Facility Name
1245.52.040 Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
Country
Japan
Facility Name
1245.52.010 Boehringer Ingelheim Investigational Site
City
Maebashi, Gunma
Country
Japan
Facility Name
1245.52.080 Boehringer Ingelheim Investigational Site
City
Maebashi, Gunma
Country
Japan
Facility Name
1245.52.050 Boehringer Ingelheim Investigational Site
City
Matsuyama, Ehime
Country
Japan
Facility Name
1245.52.075 Boehringer Ingelheim Investigational Site
City
Meguro-ku, Tokyo
Country
Japan
Facility Name
1245.52.056 Boehringer Ingelheim Investigational Site
City
Miyazaki, Miyazaki
Country
Japan
Facility Name
1245.52.057 Boehringer Ingelheim Investigational Site
City
Miyazaki, Miyazaki
Country
Japan
Facility Name
1245.52.079 Boehringer Ingelheim Investigational Site
City
Morioka, Iwate
Country
Japan
Facility Name
1245.52.003 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1245.52.004 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1245.52.005 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1245.52.038 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1245.52.059 Boehringer Ingelheim Investigational Site
City
Naha, Okinawa
Country
Japan
Facility Name
1245.52.066 Boehringer Ingelheim Investigational Site
City
Naha, Okinawa
Country
Japan
Facility Name
1245.52.065 Boehringer Ingelheim Investigational Site
City
Nanjyo, Okinawa
Country
Japan
Facility Name
1245.52.007 Boehringer Ingelheim Investigational Site
City
Oita, Oita
Country
Japan
Facility Name
1245.52.053 Boehringer Ingelheim Investigational Site
City
Okawa, Fukuoka
Country
Japan
Facility Name
1245.52.068 Boehringer Ingelheim Investigational Site
City
Okinawa, Okinawa
Country
Japan
Facility Name
1245.52.042 Boehringer Ingelheim Investigational Site
City
Osaka,Osaka
Country
Japan
Facility Name
1245.52.089 Boehringer Ingelheim Investigational Site
City
Osaki, Miyagi
Country
Japan
Facility Name
1245.52.024 Boehringer Ingelheim Investigational Site
City
Ota-ku, Tokyo
Country
Japan
Facility Name
1245.52.054 Boehringer Ingelheim Investigational Site
City
Saga, Saga
Country
Japan
Facility Name
1245.52.032 Boehringer Ingelheim Investigational Site
City
Sagamihara, Kanagawa
Country
Japan
Facility Name
1245.52.085 Boehringer Ingelheim Investigational Site
City
Sagamihara, Kanagawa
Country
Japan
Facility Name
1245.52.013 Boehringer Ingelheim Investigational Site
City
Saitama, Saitama
Country
Japan
Facility Name
1245.52.015 Boehringer Ingelheim Investigational Site
City
Sakado, Saitama
Country
Japan
Facility Name
1245.52.044 Boehringer Ingelheim Investigational Site
City
Sakai, Osaka
Country
Japan
Facility Name
1245.52.035 Boehringer Ingelheim Investigational Site
City
Saku, Nagano
Country
Japan
Facility Name
1245.52.009 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1245.52.025 Boehringer Ingelheim Investigational Site
City
Setagaya-ku, Tokyo
Country
Japan
Facility Name
1245.52.063 Boehringer Ingelheim Investigational Site
City
Shimajiri-gun, Okinawa
Country
Japan
Facility Name
1245.52.064 Boehringer Ingelheim Investigational Site
City
Shimajiri-gun, Okinawa
Country
Japan
Facility Name
1245.52.001 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku. Tokyo
Country
Japan
Facility Name
1245.52.036 Boehringer Ingelheim Investigational Site
City
Shizuoka, Shizuoka
Country
Japan
Facility Name
1245.52.006 Boehringer Ingelheim Investigational Site
City
Suita, Osaka
Country
Japan
Facility Name
1245.52.043 Boehringer Ingelheim Investigational Site
City
Takatsuki, Osaka
Country
Japan
Facility Name
1245.52.017 Boehringer Ingelheim Investigational Site
City
Tokorozawa, Saitama
Country
Japan
Facility Name
1245.52.070 Boehringer Ingelheim Investigational Site
City
Tokorozawa, Saitama
Country
Japan
Facility Name
1245.52.061 Boehringer Ingelheim Investigational Site
City
Tomigusuku, Okinawa
Country
Japan
Facility Name
1245.52.062 Boehringer Ingelheim Investigational Site
City
Tomigusuku, Okinawa
Country
Japan
Facility Name
1245.52.041 Boehringer Ingelheim Investigational Site
City
Uji, Kyoto
Country
Japan
Facility Name
1245.52.067 Boehringer Ingelheim Investigational Site
City
Uruma, Okinawa
Country
Japan
Facility Name
1245.52.028 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan
Facility Name
1245.52.029 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan
Facility Name
1245.52.030 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan
Facility Name
1245.52.081 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan
Facility Name
1245.52.082 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan
Facility Name
1245.52.083 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan
Facility Name
1245.52.084 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28753486
Citation
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.
Results Reference
derived
PubMed Identifier
25772548
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.52_U13-1730-01-DS.pdf
Description
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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

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