4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885118

1245.15

Details and patient eligibility

About

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Enrollment: 100 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.

2. Hemoglobin A1c (HbA1c) at screening (Visit 1)

   • For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
   • For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.

3. Age between 20 and 70 years

4. Body mass index (BMI) between18.0 and 40.0 kg/m2

5. Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria

1. Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent

2. Fasted blood glucose of >240 mg/dL (>13.3 mmol/L) or a randomly determined blood glucose level of >400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.

3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.

4. Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as

   • Renal insufficiency (calculated estimated glomerular filtration rate <60)
   • Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known cardiovascular diseases including hypertension of >160/95 mmHg,
   • Neurological disorders (such as epilepsy) or psychiatric disorders
   • Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
   • Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder

5. Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:

   • Statins.
   • Antihypertensives (diuretics not allowed)
   • alpha-Blockers for benign prostate hypertrophy
   • Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol

6. Additional inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 5 patient groups, including a placebo group

BI 10773 low dose quaque die (QD)

Experimental group

Description:

patient to receive a BI 10773 low dose tablet and a placebo tablet once daily

Treatment:

Drug: Placebo (low dose)

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 mid-low dose QD

Experimental group

Description:

patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily

Treatment:

Drug: Placebo (middle dose)

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 mid-high dose QD

Experimental group

Description:

patient to receive two tablets of BI 10773 middle dose once daily

Treatment:

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 high dose QD

Experimental group

Description:

patient to receive a BI 10773 high dose tablet and a placebo tablet once daily

Treatment:

Drug: Placebo (high dose)

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Placebo

Placebo Comparator group

Description:

patient to receive two tablets of placebo once daily

Treatment:

Drug: Placebo