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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Placebo

BI 187004

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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)

Sites / Locations

1307.2.1 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

BI 187004 dose 1

BI 187004 dose 2

BI 187004 dose 3

BI 187004 dose 4

BI 187004 dose 5

BI 187004 dose 6

Placebo

BI 187004 dose 7

Arm Description

multiple dose given over 14 days

placebo

multiple dose given over 14 days

Outcomes

Primary Outcome Measures

Occurrence of adverse events

Secondary Outcome Measures

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)

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

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

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

Full Information

NCT ID

NCT01874483

First Posted

June 7, 2013

Last Updated

January 26, 2016

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01874483

Brief Title

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

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 187004 dose 1

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Arm Title

BI 187004 dose 2

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Arm Title

BI 187004 dose 3

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Arm Title

BI 187004 dose 4

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Arm Title

BI 187004 dose 5

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Arm Title

BI 187004 dose 6

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Arm Title

BI 187004 dose 7

Arm Type

Experimental

Arm Description

multiple dose given over 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 2

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 4

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 5

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 6

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 7

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 1

Intervention Type

Drug

Intervention Name(s)

BI 187004

Intervention Description

BI 187004, dose 3

Primary Outcome Measure Information:

Title

Occurrence of adverse events

Time Frame

up to 15 days postdose

Secondary Outcome Measure Information:

Title

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)

Time Frame

up to 8 days postdose

Title

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

Time Frame

up to 8 days postdose

Title

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

Time Frame

up to 8 days postdose

Title

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

Time Frame

up to 8 days postdose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 Exclusion criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1307.2.1 Boehringer Ingelheim Investigational Site

City

Neuss

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

36343645

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.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus

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