CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
BI 10773 Placebo +7 moredrug
Likely dose
BI 10773 Placebo 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01924767
NCT01924767Phase 1Completed

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Multiple Rising Oral Doses (2.5 mg to 100 mg) of BI 10773 Tablets in Male and Female Type 2 Diabetic Patients

Boehringer Ingelheim·interventional·Posted Aug 16, 2013·Updated Jul 4, 2014

In Brief

A Phase 1 clinical trial evaluating BI 10773 Placebo and BI 10773 for Diabetes Mellitus, Type 2. Completed, enrolled 48 participants across 1 site.

Detailed Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2013
Enrollment StartJul 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.9 years ago

Interventions

BI 10773 Placebodrug

po taken fasting with 240 mL water

BI 10773drug

po taken fasting with 240 mL water

BI 10773 Placebodrug

po taken fasting with 240 mL water

BI 10773drug

po taken fasting with 240 mL water

BI 10773 Placebodrug

po taken fasting with 240 mL water

BI 10773 Placebodrug

po taken fasting with 240 mL water

BI 10773drug

po taken fasting with 240 mL water

BI 10773drug

po taken fasting with 240 mL water