Clinical trial NCT01874483: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 187004 CL in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.


Eligibility criteria: Inclusion criteria:

1. Type 2 diabetes mellitus
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:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal that the investigator considers to be of not acceptable clinical relevance
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)

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: up to 15 days postdose
Secondary outcomes:
measure: AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
timeFrame: up to 8 days postdose
measure: Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)
timeFrame: up to 8 days postdose
measure: AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
timeFrame: up to 8 days postdose
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
timeFrame: up to 8 days postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 1307.2.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.