A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insulin

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000474-16-NL

Enrollment

580

Registered

2020-10-21

Start date

2020-11-19

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: insulin icodec 700 U/mL PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin icodec CAS Number: *MASKED* Other descriptive name: INSULIN 287 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female aged above or equal to 18 years at the time of signing informed consent. - Diagnosed with T2D 180 days or more prior to the day of screening. - HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. - 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, insulin glulisine) 90 days or more prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses 90 days or more prior to screening: -Metformin -Sulfonylureas -Meglitinides (glinides) -Dipeptidyl peptidase-4 (DPP-4) inhibitors -Sodium-glucose Cotransporter-2 (SGLT2) inhibitors -Thiazolidinediones -Alpha-glucosidase inhibitors -Oral combination products (for the allowed individual oral anti-diabetic drugs) -Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists - Body mass index (BMI) equal to or below 40.0 kg/m^2 . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 348 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 232

Exclusion criteria

Exclusion criteria: - Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening. - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. - Chronic heart failure classified as being in New York Heart Association Class IV at screening. - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To compare safety with once weekly insulin icodec versus once daily insulin glargine, both in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 26 (V28);Main Objective: To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes (T2D) on a basal-bolus regimen. This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.	—

Measure

Time frame

Secondary Objective: To compare safety with once weekly insulin icodec versus once daily insulin glargine, both in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 26 (V28);Main Objective: To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes (T2D) on a basal-bolus regimen. This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in fasting plasma glucose (FPG) 2. Time in target-range 3.9–10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 3. Number of severe hypoglycaemic episodes (level 3) 4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) 5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 6. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 7. Time spent above 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 8. Mean weekly insulin dose 9. Change in body weight;Timepoint(s) of evaluation of this end point: 1. From baseline week 0 (V2) to week 26 (V28) 2. From week 22 (V24) to week 26 (V28) 3.-5. From baseline week 0 (V2) to week 31 (V30) 6.-7. From week 22 (V24) to week 26 (V28) 8. From week 24 (V26) to week 26 (V28) 9. From baseline week 0 (V2) to week 26 (V28)	—

Measure

Time frame

Secondary end point(s): 1. Change in fasting plasma glucose (FPG) 2. Time in target-range 3.9–10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 3. Number of severe hypoglycaemic episodes (level 3) 4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) 5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 6. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 7. Time spent above 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 8. Mean weekly insulin dose 9. Change in body weight;Timepoint(s) of evaluation of this end point: 1. From baseline week 0 (V2) to week 26 (V28) 2. From week 22 (V24) to week 26 (V28) 3.-5. From baseline week 0 (V2) to week 31 (V30) 6.-7. From week 22 (V24) to week 26 (V28) 8. From week 24 (V26) to week 26 (V28) 9. From baseline week 0 (V2) to week 26 (V28)

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Countries

European Union, India, Japan, Mexico, Netherlands, Russian Federation, United States

Contacts

Public ContactClinical Disclosure (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026