At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 enrolled
Drug / intervention
Faster-acting insulin aspart +1 moredrug
Likely dose
Not stated in 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.
Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Faster-acting insulin aspart and basal insulin for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 323 participants across 58 sites in 6 countries.
Detailed Summary
This trial is conducted in Asia, Europe, South America, and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, India, Mexico, Romania, Slovenia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartSep 2013
Primary CompletionNov 2014
TodayJul 2026
First PostedMay 9, 2013
Enrollment StartSep 23, 2013
Primary CompletionNov 17, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.1 years ago
Interventions
Faster-acting insulin aspartdrug
Administrated subcutaneously (s.c., under the skin) at each main meal.
basal insulindrug
Administrated subcutaneously (s.c., under the skin) once daily.