A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen. ONWARDS 4.

Phase 3

• Conditions: Health Condition 1: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2021/06/034231
• Lead Sponsor: ovo Nordisk Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Informed consent obtained before any trial-related activities. Trial-related activities are any

procedures that are carried out as part of the trial, including activities to determine suitability

for the trial.

2. Male or female.

3. Age above or equal to 18 years at the time of signing informed consent.

4. Diagnosed with T2D >= 180 days prior to the day of screening.

5. HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by

central laboratory analysis.

6. Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec,

insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4

daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin

lispro, faster acting insulin lispro, insulin glulisine) >= 90 days prior to the day of screening

with or without any of the following anti-diabetic drugs/regimens with stable doses >= 90

days prior to screening:

• Metformin

• Sulfonylureas

• Meglitinides (glinides)

• DPP-4 inhibitors

• SGLT2 inhibitors

• Thiazolidinediones

• Alpha-glucosidase inhibitors

• Oral combination products (for the allowed individual oral anti-diabetic

drugs)

• Oral or injectable GLP-1 RAs

7. Body mass index (BMI) <= 40.0 kg/m2.

Exclusion Criteria

Subjects are excluded from the trial if any of the following criteria apply:

1. Known or suspected hypersensitivity to trial product(s) or related products.

2. Previous participation in this trial. Participation is defined as signed informed consent.

3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing

potential and not using an adequate contraceptive method (adequate contraceptive measures

as required by local regulation or practice).

4. Participation in any clinical trial of an approved or non-approved investigational medicinal

product within 90 days before screeninga.

Study & Design

• Study Type: Interventional
• Study Design: Not specified