A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

Conditions

• Diabetes Mellitus, Type 1

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• insulin icodec — DRUG
  insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
• insulin degludec — DRUG
  insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily
• insulin aspart — DRUG
  insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily

Study Details

This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Key Dates

Start date

Apr 30, 2021

Status verified

Nov 2025

Primary completion

Apr 28, 2022

Completion

Dec 2, 2022

Study Design

Enrollment

582 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Insulin icodec + insulin aspart
  insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.
• Active Comparator: Insulin degludec + insulin aspart
  insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline (week 0), week 26 ]

Locations (42)

Related coverage on Hipa.ai

• Liraglutide-Related Trial: Insulin Icodec Less Effective in Type 1 Diabetes
  Liraglutide · Jun 12, 2025 · ClinicalTrials.gov

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