BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Medium dose of BI 1356 BS; Drug: High dose of BI 1356 BS; Drug: Low dose of BI 1356 BS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183324

1218.12

Details and patient eligibility

About

Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese patients with type 2 diabetes mellitus.

Enrollment: 72 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese patients with a diagnosis of type 2 diabetes mellitus treated with diet and/or exercise only or with one or two oral hypoglycaemic agents except glitazones

• Glycosylated haemoglobin A1 (HbA1c)

  • <= 8.5% at screening for patients treated with diet and/or exercise and/or one oral hypoglycaemic agent or
  • <= 8.0% at screening for patients treated with two oral hypoglycaemic agents

• Age ≥21 and ≤ 70 years

• BMI ≥ 17.6 and ≤ 35 kg/m2

Exclusion criteria

• Any finding of the medical examination including blood pressure, pulse rate and electrocardiogram (ECG) deviating from normal and of not acceptable clinical relevance
• Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency (NYHA II-IV), known cardiovascular diseases including hypertension (>150/95 mmHg), stroke, and transient ischemic attack (TIA).
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, except for type 2 diabetes mellitus, hyperlipidaemia and medically treated hypertension
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders except polyneuropathy
• Chronic or relevant acute infections (e.g., human immunodeficiency virus (HIV), hepatitis)
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug before drug administration except anti-hypertensives, acetylsalicylic acid, and statins
• Use of drugs decreasing blood glucose within 10 days before drug administration
• Participation in another trial with an investigational drug within two months before drug administration
• Alcohol abuse
• Drug abuse
• Blood donation (100 mL or more within four weeks before drug administration)
• Excessive physical activities (within one week before drug administration or during the trial)
• Any laboratory value outside the reference range and the clinical relevance is not acceptable (or the value is more than three times higher than the upper limit of the normal range, e.g., liver enzymes such as aspartate aminotransferase (AST(serum glutamate oxaloacetate transaminase/ SGOT)), alanine transaminase (ALT(serum glutamate pyruvate transaminase/ SGPT)), alkaline phosphatase (γALP), and lactate dehydrogenase (LDH)
• Fasted blood glucose >240 mg/dL (=13.3 mmol/L) on two consecutive days during washout
• Serum creatinine above 1.3 mg/dL at screening
• Pregnancy or child-bearing potential patients and breast-feeding patients
• Not willing to use adequate contraception (condom use plus another form of contraception, e.g., spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

Low dose of BI 1356 BS

Experimental group

Treatment:

Drug: Low dose of BI 1356 BS

Medium dose of BI 1356 BS

Experimental group

Treatment:

Drug: Medium dose of BI 1356 BS

High dose of BI 1356 BS

Experimental group

Treatment:

Drug: High dose of BI 1356 BS

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo