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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 187004; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874483

1307.2

2013-000312-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 8 patient groups, including a placebo group

BI 187004 dose 1

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

BI 187004 dose 2

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

BI 187004 dose 3

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

BI 187004 dose 4

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

BI 187004 dose 5

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

BI 187004 dose 6

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo

BI 187004 dose 7

Experimental group

Description:

multiple dose given over 14 days

Treatment:

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004

Drug: BI 187004