CompletedPhase 3

A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)

United States, Argentina, Austria588 participantsStarted 2021-03-24

Plain-language summary

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get. The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female aged above or equal to 18 years at the time of signing informed consent. * Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening. * HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. * Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. * Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a.) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b.) Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c.) Any of the following oral anti-diabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - Oral or injectable GLP-1-receptor agonists * Body mass index (BMI) below or equal to 40.0 kg/m\^2. Exclusion Criteria: * Any episodes (as declared by the subje…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared a once-weekly insulin called icodec to a once-daily insulin called degludec in people with type 2 diabetes who had never used insulin before — since the study is now completed, what do the results show about how well icodec lowered HbA1c compared to degludec, and what does that mean for my situation?
2Because insulin icodec is injected only once a week instead of once a day, is that dosing schedule something that could realistically work with my lifestyle, and are there any safety concerns around having a weekly insulin 'active' in my body for longer periods?
3This was a Phase 3 trial, which means it was testing effectiveness in a larger group — but what do the completed results tell us about the risk of low blood sugar (hypoglycemia) with weekly icodec compared to daily degludec, especially since I haven't used insulin before?
4Since the trial specifically enrolled people with type 2 diabetes who were insulin-naive, like me, does my doctor think the findings from this study are directly relevant to my current treatment plan, or would starting with a more established insulin option first make more sense?
5Now that this trial is completed, is insulin icodec approved or available yet, and if not, what is my best current option for starting insulin therapy while we wait to see how regulators respond to this research?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Glycated Haemoglobin (HbA1c)

Timeframe: Baseline (Week 0), Week 26

Trial details

NCT IDNCT04795531

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-23

Results submitted2024-11-10

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials