NCT01874483

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

June 7, 2013

Last Update Submit

January 26, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    up to 15 days postdose

Secondary Outcomes (4)

  • 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)

    up to 8 days postdose

  • Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)

    up to 8 days postdose

  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)

    up to 8 days postdose

  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)

    up to 8 days postdose

Study Arms (8)

BI 187004 dose 1

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

BI 187004 dose 2

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

BI 187004 dose 3

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

BI 187004 dose 4

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

BI 187004 dose 5

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

BI 187004 dose 6

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

BI 187004 dose 7

EXPERIMENTAL

multiple dose given over 14 days

Drug: BI 187004

Interventions

PlaceboDRUG

placebo

Placebo
BI 187004DRUG

BI 187004, dose 2

BI 187004 dose 2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues)
  • Males or post-menopausal or surgically sterilised females
  • Age from 20 and to 70 years
  • HbA1c less or equal to 8.5%
  • BMI 28-40 kg/m2
  • Subjects must be able to understand an comply with study requirements

You may not qualify if:

  • 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
  • Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg
  • Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
  • Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
  • Chronic or relevant acute infections (e.g. HIV, hepatitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1307.2.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36343645DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2013

First Posted

June 11, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

DE(1)