ONWARDS 6-4625: Insulin icodec in adults with Type 1 Diabetes

• Research type

  Research Study

• Full title

  Efficacy and safety of once weekly insulin icodec compared to once daily insulin degludec 100 units/mL, both in combination with insulin aspart, in adults with type 1 diabetes. A 26-week, randomised, multicentre, open-label, active-controlled, parallel group, two armed, treat-to-target trial investigating the effect on glycaemic control and safety of treatment with once weekly insulin icodec compared to once daily insulin degludec, both in combination with insulin aspart in adults with type 1 diabetes, with a 26-week extension investigating long term safety.

• IRAS ID

  295102

• Contact name

  Clinical Transparency (Dept. 1452)

• Contact email

  pactadmin@novonordisk.com

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2020-002374-27

• Clinicaltrials.gov Identifier

  NCT04848480

• Clinicaltrials.gov Identifier

  Universal Trial Number, U1111-1251-7315

• Duration of Study in the UK

  1 years, 7 months, 24 days

• Research summary

  Research Summary

  This study is being carried out to compare how well a new insulin called insulin icodec controls blood sugar levels in patients with Type 1 Diabetes Mellitus (T1D).

  Insulin is a hormone that helps the body control blood sugar. T1D is an illness characterised by defective insulin secretion, insulin action or both. Currently basal insulin treatments are dosed once or twice daily. Insulin icodec is a new insulin that is being developed by the company Novo Nordisk A/S to safely cover the basal insulin requirements of patients with diabetes in a once weekly injection.

  This study will compare how well once-weekly icodec controls blood sugar levels over a 26-week treatment period compared to insulin degludec, an insulin that is already available and is given as a once daily injection. A 26-week extension treatment period will allow evaluation of long-term safety.

  If eligible, participants will be randomised to receive either insulin icodec given once weekly, or insulin degludec given once daily, both in combination with mealtime insulin (insulin aspart). All treatments are administered by a subcutaneous (under the skin) injection.

  The study duration is approximately 59 weeks; consisting of a 2-week screening period, followed by a 52-week randomised treatment period and a 5-week follow-up period. The study consists of 28 clinic visits and 28 phone calls.

  The study plans to include 580 participants across 12 countries. In the UK, the planned number of participants is 45 across 8 sites.

  Summary of Results

  Lay summary of results for Novo Nordisk studies are published on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbaYx4QiZUJwMcb5kBil-2Fqo0FVzkim1UNcn7Q1MygFnqVlzIL_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLA6YXPhjhVe4s1zjuk5WXhXpREVM34fp1uq8BkPq6RZ-2BXptrvSHbDQN2W4LwocdXoKMqfXY52y-2BcOaEmL-2FIBHWtxInkzJP-2FIXeH1IKiRemo-2BTM5r3KoIlp3l8U637L6-2B6uTRFr9bU0u5s2CNxiWQgDNfoUi-2BOxExh1wKY2y6e78Q-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C333e7b2eddde44e3938008db65f37fe3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638215868714023106%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=XjMxnkpTrgTSJ7YWnr72PHv8m5%2FK3pghAyr1j5dxkQo%3D&reserved=0

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  21/EM/0044

• Date of REC Opinion

  11 Mar 2021

• REC opinion

  Further Information Favourable Opinion