NCT03268005|CompletedPhase 3ResultsFDA Drug

Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

onset 9

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 ClinicalTrials.gov

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3 other identifiers

NN1218-4113U1111-1180-06362016-000878-38

Study Type

interventional

Target

1,264

Locations

18 countries

Sites

167

Timeline

RegisteredAug 2017

StartedSep 2017

CompletionJan 2019

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,264

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 2017

Typical duration for phase_3 diabetes

Geographic Reach

18 countries

167 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

August 29, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed

19 days until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed

22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 12, 2020

Completed

Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

August 29, 2017

Results QC Date

January 7, 2020

Last Update Submit

January 6, 2022

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
Week 0, week 16

Secondary Outcomes (51)

Change From Baseline in 1-hour PPG Increment
Week 0, week 16
Change From Baseline in 1,5-anhydroglucitol
Week 0, week 16
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 16
Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
16 weeks after randomisation
Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
16 weeks after randomisation
+46 more secondary outcomes

Study Arms (2)

Faster aspart + insulin degludec with or without metformin

EXPERIMENTAL

Drug: Faster-acting insulin aspartDrug: Insulin degludecDrug: Metformin

NovoRapid/NovoLog + insulin degludec with or without metformin

ACTIVE COMPARATOR

Drug: Insulin aspartDrug: Insulin degludecDrug: Metformin

Interventions

Faster-acting insulin aspartDRUG

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

Faster aspart + insulin degludec with or without metformin

Insulin aspartDRUG

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

NovoRapid/NovoLog + insulin degludec with or without metformin

Insulin degludecDRUG

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

Faster aspart + insulin degludec with or without metforminNovoRapid/NovoLog + insulin degludec with or without metformin

MetforminDRUG

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

Faster aspart + insulin degludec with or without metforminNovoRapid/NovoLog + insulin degludec with or without metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.