CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 881 enrolled
Drug / intervention
Faster-acting insulin aspart +2 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.

Search/NCT01819129
NCT01819129Phase 3Completed
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Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Mar 27, 2013·Updated Jan 30, 2019

In Brief

A Phase 3 clinical trial evaluating Faster-acting insulin aspart, Insulin aspart, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 881 participants across 144 sites in 10 countries.

Detailed Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesCanada, Croatia, India, Israel, Puerto Rico, Russia, Serbia, Slovakia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2013
Enrollment StartSep 9, 2013
Primary CompletionJan 22, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.3 years ago

Interventions

Faster-acting insulin aspartdrug

Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Insulin aspartdrug

Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Insulin glarginedrug

Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.