ONWARDS 1- 4477: Insulin Icodec in Patients with Type 2 Diabetes
Research type
Research Study
Full title
ONWARDS 1: A 78-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with non-insulin anti-diabetic treatment, in insulin naïve subjects with type 2 diabetes.
IRAS ID
287075
Contact name
Clinical Transparency (Dept. 1452)
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2020-000442-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Universal Trial Number, U1111-1247-3878
Duration of Study in the UK
2 years, 0 months, 6 days
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 2 Diabetes Mellitus (T2D).
T2D is an illness where the body does not make enough insulin. Insulin is a hormone that helps the body control blood sugar. This means that patients with T2D experience raised blood sugar levels and patients may ultimately need treatment with insulin.
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 T2D in a once weekly injection. This study will compare how well once-weekly icodec controls blood sugar levels over a 78-week treatment period compared to insulin glargine, an insulin that is already available and is given as a once daily injection.
If eligible, participants will be randomised to receive either insulin icodec given once weekly, or insulin glargine given once daily. All treatments are administered by a subcutaneous (under the skin) injection.
The study duration is approximately 85 weeks; consisting of a 2-week screening period, followed by a 78-week randomised treatment period and a 5-week follow-up period. The study consists of 37 clinic visits and 26 phone calls. The study plans to include 970 participants across 12 countries. In the UK, the planned number of participants is 70 across 15 sites.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0298
Date of REC Opinion
24 Aug 2020
REC opinion
Favourable Opinion