BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
NCT ID: NCT02183324
Last Updated: 2017-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose of BI 1356 BS
Low dose of BI 1356 BS
Medium dose of BI 1356 BS
Medium dose of BI 1356 BS
High dose of BI 1356 BS
High dose of BI 1356 BS
Placebo
Placebo
Interventions
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Low dose of BI 1356 BS
Medium dose of BI 1356 BS
High dose of BI 1356 BS
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Related Links
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Related Info
Other Identifiers
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1218.12
Identifier Type: -
Identifier Source: org_study_id