CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,108 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/NCT02500706
NCT02500706Phase 3Completed
CompareCT.gov

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

Novo Nordisk A/S·interventional·Posted Jul 16, 2015·Updated Jun 12, 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 1. Completed, enrolled 1,108 participants across 152 sites in 13 countries.

Detailed Summary

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesAustria, Bulgaria, Canada, Germany, India, Israel, Italy, Japan, Puerto Rico, Russia, Serbia, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 16, 2015
Enrollment StartMay 4, 2016
Primary CompletionJul 17, 2017
Study CompletionAug 16, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.0 years ago

Interventions

Faster-acting insulin aspartdrug

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

insulin aspartdrug

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.

insulin degludecdrug

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted