Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin

Phase 2

Completed

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

• Registration Number: NCT02150824
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Study Start: 2014-07
• Primary Completion: 2015-07
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 low dose mono QD	Placebo	patient to receive one tablet containing low dose of BI 187004 or matching placebo
BI 187004 low dose mono QD	BI 187004	patient to receive one tablet containing low dose of BI 187004 or matching placebo
BI 187004 medium dose mono QD	Placebo	patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
BI 187004 medium dose mono QD	BI 187004	patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
BI 187004 high dose mono QD	Placebo	patient to receive one tablet containing high dose of BI 187004 or matching placebo
BI 187004 high dose mono QD	BI 187004	patient to receive one tablet containing high dose of BI 187004 or matching placebo
BI 187004 high dose QD add on	Placebo	patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose
BI 187004 high dose QD add on	BI 187004	patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose

Primary Outcome Measures

Name	Time	Method
The percentage of patients with drug- related adverse events	6 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment	4 weeks

Trial Locations

Locations (3)

1307.4.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Mainz, Germany

1307.4.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany

1307.4.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany