CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
BI 10773 +4 moredrug
Likely dose
BI 10773 50 mg, oral, single doseAI-extracted
Key inclusion· 4
  • ✓Type 2 diabetes mellitus diagnosis (male or female)
  • ✓Age 18–75 years
  • ✓BMI 18–34 kg/m², minimum 45 kg for females
  • ✓Renal impairment (various degrees) or normal renal function
Key exclusion· 7
  • ✕Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • ✕History of CNS disease (epilepsy, seizures) or psychiatric/neurological disorders
  • ✕Orthostatic hypotension, fainting, blackouts; BP <100 or >160 mmHg systolic, <60 or >100 mmHg diastolic; HR <50 or >100 bpm
  • ✕Chronic or acute infections

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

Search/NCT01907113
NCT01907113Phase 1Completed
CompareCT.gov

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single 50 mg Dose of BI 10773 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Type 2 Diabetes and Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase 1 Trial

Boehringer Ingelheim·interventional·Posted Jul 24, 2013·Updated Jul 14, 2014

In Brief

A Phase 1 clinical trial evaluating BI 10773 for Diabetes Mellitus, Type 2. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2013
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.9 years ago

Interventions

BI 10773drug

oral administration

BI 10773drug

oral administration

BI 10773drug

oral administration

BI 10773drug

oral administration

BI 10773drug

oral administration