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Insulin

Insulin icodec for Type 2 Diabetes (ONWARDS 5 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline week 0 (v2) to week 57 (v8)
Awards & highlights

Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes. The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App. The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline week 0 (v2) to week 57 (v8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline week 0 (v2) to week 57 (v8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HbA1c (glycated haemoglobin)
Secondary study objectives
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
+3 more

Side effects data

From 2020 Phase 2 trial • 247 Patients • NCT03751657
11%
Headache
8%
Nasopharyngitis
6%
Upper respiratory tract infection
1%
Lower limb fracture
1%
Metrorrhagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin 287
Insulin Glargine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin icodec with DoseGuideExperimental Treatment1 Intervention
Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.
Group II: Once daily basal insulin analoguesActive Control3 Interventions
Participants randomised to basal insulin analogue injections once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin icodec
2021
Completed Phase 3
~4140

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,543 Previous Clinical Trials
2,441,590 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,070 Total Patients Enrolled
~241 spots leftby Sep 2025