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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874483
• Other study ID #: 1307.2
• Secondary ID: 2013-000312-21
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2013
• Last updated: January 26, 2016
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	1307.2.1 Boehringer Ingelheim Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events		up to 15 days postdose	No
Secondary	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	No
Secondary	Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)		up to 8 days postdose	No
Secondary	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	No
Secondary	Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)		up to 8 days postdose	No

External Links

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