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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 187004; Drug: Placebo

• Registration Number: NCT01874483
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 187004 dose 1	BI 187004	multiple dose given over 14 days
BI 187004 dose 2	BI 187004	multiple dose given over 14 days
BI 187004 dose 3	BI 187004	multiple dose given over 14 days
BI 187004 dose 4	BI 187004	multiple dose given over 14 days
BI 187004 dose 5	BI 187004	multiple dose given over 14 days
BI 187004 dose 6	BI 187004	multiple dose given over 14 days
Placebo	Placebo	placebo
BI 187004 dose 7	BI 187004	multiple dose given over 14 days

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	up to 15 days postdose

Secondary Outcome Measures

Name	Time	Method
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
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
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)	up to 8 days postdose

Trial Locations

Locations (1)

1307.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany