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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

NCT02150824 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-08-14

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

BI 187004 high dose matching placebo once daily

DRUG

Placebo

BI 187004 medium dose matching placebo once daily

DRUG

Placebo

BI 187004 high dose matching placebo once daily add on to background metformin

DRUG

BI 187004

BI 187004 high dose once daily add on to background metformin

DRUG

Placebo

BI 187004 low dose matching placebo once daily

DRUG

BI 187004

BI 187004 medium dose once daily

DRUG

BI 187004

BI 187004 low dose once daily

DRUG

BI 187004

BI 187004 high dose once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150824 on ClinicalTrials.gov