CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,290 enrolled
Drug / intervention
Faster-acting insulin aspart +3 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/NCT01831765
NCT01831765Phase 3Completed
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Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

Novo Nordisk A/S·interventional·Posted Apr 15, 2013·Updated Jun 12, 2019

In Brief

A Phase 3 clinical trial evaluating Faster-acting insulin aspart, insulin detemir, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 1,290 participants across 191 sites in 9 countries.

Detailed Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesBelgium, Canada, Czechia, Finland, Germany, Hungary, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2013
Enrollment StartAug 26, 2013
Primary CompletionMay 12, 2015
Study CompletionJun 11, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.2 years ago

Interventions

Faster-acting insulin aspartdrug

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.

insulin detemirdrug

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.

insulin aspartdrug

Injected subcutaneously (s.c., under the skin), dose individually adjusted.

Faster-acting insulin aspartdrug

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.