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

NCT ID: NCT01368081

Last Updated: 2014-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 10773 low dose

BI 10773 low dose tablet once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 low dose tablet once daily

Placebo (high dose)

Intervention Type DRUG

Placebo tablets once daily

BI 10773 high dose

BI 10773 high dose tablet once daily

Group Type EXPERIMENTAL

Placebo (low dose)

Intervention Type DRUG

Placebo tablets once daily

BI 10773

Intervention Type DRUG

BI 10773 high dose tablet once daily

Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Interventions

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Metformin

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

Intervention Type DRUG

BI 10773

BI 10773 low dose tablet once daily

Intervention Type DRUG

Placebo (low dose)

Placebo tablets once daily

Intervention Type DRUG

BI 10773

BI 10773 high dose tablet once daily

Intervention Type DRUG

Placebo (high dose)

Placebo tablets once daily

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.52.023 Boehringer Ingelheim Investigational Site

Adachi-ku, Tokyo, , Japan

Site Status

1245.52.048 Boehringer Ingelheim Investigational Site

Aki-gun, Hiroshima, , Japan

Site Status

1245.52.012 Boehringer Ingelheim Investigational Site

Annaka, Gunma, , Japan

Site Status

1245.52.087 Boehringer Ingelheim Investigational Site

Atami, Shizuoka, , Japan

Site Status

1245.52.008 Boehringer Ingelheim Investigational Site

Beppu, Oita, , Japan

Site Status

1245.52.073 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1245.52.002 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.52.020 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.52.021 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.52.031 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, , Japan

Site Status

1245.52.077 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

1245.52.086 Boehringer Ingelheim Investigational Site

Hadano, Kanagawa, , Japan

Site Status

1245.52.037 Boehringer Ingelheim Investigational Site

Hamamatsu, Shizuoka, , Japan

Site Status

1245.52.046 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

Site Status

1245.52.047 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, , Japan

Site Status

1245.52.051 Boehringer Ingelheim Investigational Site

Imabari, Ehime, , Japan

Site Status

1245.52.016 Boehringer Ingelheim Investigational Site

Iruma,Saitama, , Japan

Site Status

1245.52.033 Boehringer Ingelheim Investigational Site

Isehara, Kanagawa, , Japan

Site Status

1245.52.011 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, , Japan

Site Status

1245.52.045 Boehringer Ingelheim Investigational Site

Izumisano,Osaka, , Japan

Site Status

1245.52.088 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, , Japan

Site Status

1245.52.072 Boehringer Ingelheim Investigational Site

Kamakura,Kanagawa, , Japan

Site Status

1245.52.034 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, , Japan

Site Status

1245.52.058 Boehringer Ingelheim Investigational Site

Kanoya, Kagoshima, , Japan

Site Status

1245.52.019 Boehringer Ingelheim Investigational Site

Kashiwa, Chiba, , Japan

Site Status

1245.52.039 Boehringer Ingelheim Investigational Site

Kasugai, Aichi, , Japan

Site Status

1245.52.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

Site Status

1245.52.018 Boehringer Ingelheim Investigational Site

Kita-adachi-gun, Saitama, , Japan

Site Status

1245.52.022 Boehringer Ingelheim Investigational Site

Kita-ku, Tokyo, , Japan

Site Status

1245.52.052 Boehringer Ingelheim Investigational Site

Kitakyushu, Fukuoka, , Japan

Site Status

1245.52.076 Boehringer Ingelheim Investigational Site

Kobe, Hyogo, , Japan

Site Status

1245.52.026 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, , Japan

Site Status

1245.52.069 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

Site Status

1245.52.071 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

Site Status

1245.52.014 Boehringer Ingelheim Investigational Site

Koshigaya, Saitama, , Japan

Site Status

1245.52.074 Boehringer Ingelheim Investigational Site

Kuki, Saitama, , Japan

Site Status

1245.52.055 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, , Japan

Site Status

1245.52.049 Boehringer Ingelheim Investigational Site

Kure, Hiroshima, , Japan

Site Status

1245.52.040 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

1245.52.010 Boehringer Ingelheim Investigational Site

Maebashi, Gunma, , Japan

Site Status

1245.52.080 Boehringer Ingelheim Investigational Site

Maebashi, Gunma, , Japan

Site Status

1245.52.050 Boehringer Ingelheim Investigational Site

Matsuyama, Ehime, , Japan

Site Status

1245.52.075 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, , Japan

Site Status

1245.52.056 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, , Japan

Site Status

1245.52.057 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, , Japan

Site Status

1245.52.079 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

Site Status

1245.52.003 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1245.52.004 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1245.52.005 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1245.52.038 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1245.52.059 Boehringer Ingelheim Investigational Site

Naha, Okinawa, , Japan

Site Status

1245.52.066 Boehringer Ingelheim Investigational Site

Naha, Okinawa, , Japan

Site Status

1245.52.065 Boehringer Ingelheim Investigational Site

Nanjyo, Okinawa, , Japan

Site Status

1245.52.007 Boehringer Ingelheim Investigational Site

Oita, Oita, , Japan

Site Status

1245.52.053 Boehringer Ingelheim Investigational Site

Okawa, Fukuoka, , Japan

Site Status

1245.52.068 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, , Japan

Site Status

1245.52.042 Boehringer Ingelheim Investigational Site

Osaka,Osaka, , Japan

Site Status

1245.52.089 Boehringer Ingelheim Investigational Site

Osaki, Miyagi, , Japan

Site Status

1245.52.024 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, , Japan

Site Status

1245.52.054 Boehringer Ingelheim Investigational Site

Saga, Saga, , Japan

Site Status

1245.52.032 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, , Japan

Site Status

1245.52.085 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, , Japan

Site Status

1245.52.013 Boehringer Ingelheim Investigational Site

Saitama, Saitama, , Japan

Site Status

1245.52.015 Boehringer Ingelheim Investigational Site

Sakado, Saitama, , Japan

Site Status

1245.52.044 Boehringer Ingelheim Investigational Site

Sakai, Osaka, , Japan

Site Status

1245.52.035 Boehringer Ingelheim Investigational Site

Saku, Nagano, , Japan

Site Status

1245.52.009 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1245.52.025 Boehringer Ingelheim Investigational Site

Setagaya-ku, Tokyo, , Japan

Site Status

1245.52.063 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, , Japan

Site Status

1245.52.064 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, , Japan

Site Status

1245.52.001 Boehringer Ingelheim Investigational Site

Shinjuku-ku. Tokyo, , Japan

Site Status

1245.52.036 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, , Japan

Site Status

1245.52.006 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1245.52.043 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, , Japan

Site Status

1245.52.017 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, , Japan

Site Status

1245.52.070 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, , Japan

Site Status

1245.52.061 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, , Japan

Site Status

1245.52.062 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, , Japan

Site Status

1245.52.041 Boehringer Ingelheim Investigational Site

Uji, Kyoto, , Japan

Site Status

1245.52.067 Boehringer Ingelheim Investigational Site

Uruma, Okinawa, , Japan

Site Status

1245.52.028 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

1245.52.029 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

1245.52.030 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

1245.52.081 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

1245.52.082 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

1245.52.083 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

1245.52.084 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 28753486 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25772548 (View on PubMed)

Other Identifiers

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1245.52

Identifier Type: -

Identifier Source: org_study_id

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