Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo (low dose); Drug: Placebo (high dose); Drug: Placebo (mid dose); Drug: BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193218

1245.38

Details and patient eligibility

About

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.

Enrollment: 547 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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:

  1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
  2. 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:

  1. for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
  2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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547 participants in 5 patient groups, including a placebo group

BI 10773 low dose QD

Experimental group

Description:

BI 10773 tablets low dose once a day

Treatment:

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (high dose)

Drug: Placebo (high dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (mid dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (high dose)

Drug: Placebo (high dose)

Drug: BI 10773

BI 10773 mid-low dose QD

Experimental group

Description:

BI 10773 tablets mid-low dose once a day

Treatment:

Drug: Placebo (low dose)

Drug: BI 10773

Drug: Placebo (high dose)

Drug: Placebo (high dose)

Drug: Placebo (low dose)

Drug: Placebo (low dose)

Drug: BI 10773

Drug: BI 10773

Drug: Placebo (high dose)

Drug: Placebo (low dose)

Drug: Placebo (high dose)

Drug: BI 10773

BI 10773 mid-high dose QD

Experimental group

Description:

BI 10773 tablets mid-high dose once a day

Treatment:

Drug: Placebo (low dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (high dose)

Drug: Placebo (high dose)

Drug: Placebo (low dose)

Drug: Placebo (low dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (mid dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (high dose)

Drug: Placebo (low dose)

Drug: Placebo (high dose)

Drug: BI 10773

BI 10773 high dose QD

Experimental group

Description:

BI 10773 tablets high dose once a day

Treatment:

Drug: Placebo (low dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (low dose)

Drug: Placebo (low dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (mid dose)

Drug: BI 10773

Drug: Placebo (mid dose)

Drug: Placebo (low dose)

Drug: BI 10773

Placebo

Placebo Comparator group

Description:

Placebo tablets once a day

Treatment:

Drug: Placebo (low dose)

Drug: Placebo (mid dose)

Drug: Placebo (high dose)

Drug: Placebo (high dose)

Drug: Placebo (low dose)

Drug: Placebo (low dose)

Drug: Placebo (mid dose)

Drug: Placebo (mid dose)

Drug: Placebo (mid dose)

Drug: Placebo (high dose)

Drug: Placebo (low dose)

Drug: Placebo (high dose)