Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01874483
Last Updated: 2016-01-27
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
PHASE1
71 participants
INTERVENTIONAL
2013-06-30
2013-12-31
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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BI 187004 dose 1
multiple dose given over 14 days
BI 187004
BI 187004, dose 1
BI 187004 dose 2
multiple dose given over 14 days
BI 187004
BI 187004, dose 2
BI 187004 dose 3
multiple dose given over 14 days
BI 187004
BI 187004, dose 3
BI 187004 dose 4
multiple dose given over 14 days
BI 187004
BI 187004, dose 4
BI 187004 dose 5
multiple dose given over 14 days
BI 187004
BI 187004, dose 5
BI 187004 dose 6
multiple dose given over 14 days
BI 187004
BI 187004, dose 6
Placebo
placebo
Placebo
placebo
BI 187004 dose 7
multiple dose given over 14 days
BI 187004
BI 187004, dose 7
Interventions
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Placebo
placebo
BI 187004
BI 187004, dose 2
BI 187004
BI 187004, dose 4
BI 187004
BI 187004, dose 5
BI 187004
BI 187004, dose 6
BI 187004
BI 187004, dose 7
BI 187004
BI 187004, dose 1
BI 187004
BI 187004, dose 3
Eligibility Criteria
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Inclusion Criteria
2. Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues)
3. Males or post-menopausal or surgically sterilised females
4. Age from 20 and to 70 years
5. HbA1c less or equal to 8.5%
6. BMI 28-40 kg/m2
7. Subjects must be able to understand an comply with study requirements
Exclusion Criteria
2. Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg
3. Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
5. Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug
6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
7. Chronic or relevant acute infections (e.g. HIV, hepatitis)
20 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1307.2.1 Boehringer Ingelheim Investigational Site
Neuss, , Germany
Countries
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References
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Bianzano S, Schepers C, Wolff M, Heise T, Plum-Moerschel L. Selective Inhibition of 11beta-Hydroxysteroiddehydrogenase-1 with BI 187004 in Patients with Type 2 Diabetes and Overweight or Obesity: Safety, Pharmacokinetics, and Pharmacodynamics After Multiple Dosing Over 14 Days. Exp Clin Endocrinol Diabetes. 2022 Dec;130(12):773-782. doi: 10.1055/a-1932-3136. Epub 2022 Nov 7.
Other Identifiers
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2013-000312-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1307.2
Identifier Type: -
Identifier Source: org_study_id
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