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 di

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 di - ONWARDS 6

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52258

Enrollment

Registered

2021-02-17

Start date

2021-07-02

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

diabetes Diabetes Mellitus type 1

Interventions

Subjects will be randomised (1:1) to a treat-to-target basal-bolus insulin regimen with either once weekly insulin icodec or once daily insulin degludec, both in combination with insulin aspart.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Male or female aged 18 years or more at the time of signing informed consent. -Diagnosed with type 1 diabetes mellitus at least 1 year prior to the day of screening. -Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) at least 1 year prior to the day of screening. -HbA1c below 10% at screening visit based on analysis from central laboratory.

Exclusion criteria

Exclusion criteria: - Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. -Chronic heart failure classified as New York Heart Association (NYHA) 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
Change in HbA1c from baseline week 0 (V2) to week 26	—

Secondary

Measure	Time frame
Secondary efficacy endpoints -Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 -Time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week 22 to week 26 -Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction from baseline (week 0) to week 26 -Change in HbA1c from baseline (week 0) to week 52 Secondary safety endpoints -Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 26 -Number of clinically significant hypoglycaemic episodes (level 2) ( 10 mmol/L (180 mg/dL) from week 22 to week 26 -Mean total weekly insulin dose from week 24 to week 26 -Mean total weekly insulin dose from week 50 to week 52 -Change in body weight from baseline (week 0) to week 26	—

Measure

Time frame

Secondary efficacy endpoints -Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 -Time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week 22 to week 26 -Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction from baseline (week 0) to week 26 -Change in HbA1c from baseline (week 0) to week 52 Secondary safety endpoints -Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 26 -Number of clinically significant hypoglycaemic episodes (level 2) ( 10 mmol/L (180 mg/dL) from week 22 to week 26 -Mean total weekly insulin dose from week 24 to week 26 -Mean total weekly insulin dose from week 50 to week 52 -Change in body weight from baseline (week 0) to week 26

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)