CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,264 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/NCT03268005
NCT03268005Phase 3Completed
CompareCT.gov

Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9)

Novo Nordisk A/S·interventional·Posted Aug 31, 2017·Updated Jan 11, 2022

In Brief

A Phase 3 clinical trial evaluating Faster-acting insulin aspart, Insulin aspart, and 2 other interventions for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 1,264 participants across 167 sites in 18 countries.

Detailed Summary

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Bulgaria, Canada, Croatia, Czechia, Germany, Greece, Italy, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2017
Enrollment StartSep 19, 2017
Primary CompletionJan 7, 2019
Study CompletionJan 29, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.8 years ago

Interventions

Faster-acting insulin aspartdrug

Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Insulin aspartdrug

Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Insulin degludecdrug

Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Metformindrug

Only participants who took metformin before the study should take metformin tablets, same dose as before the study