Health TrialsbyHealthPanel

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.

Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.

HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.

Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Disqualifiers

Known or suspected hypersensitivity to study intervention(s) or related products.

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

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.

Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Insulin icodec

    Drug

    Insulin icodec will be administered as subcutaneous injection

  • Insulin glargine

    Drug

    Insulin glargine will be administered as subcutaneous injection.

  • Insulin aspart

    Drug

    Insulin aspart will be administered as a subcutaneous injection.

Treatment groups

877 Participants
are divided into 2 treatment groups
Group A: Insulin icodec + insulin aspartExperimental treatment 2 interventions
Group B: Insulin glargine+ insulin aspartActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in glycosylated haemoglobin (HbA1c)

Measured in percentage (%)-points.

Time frame
From baseline (week 0) to week 26

Secondary outcomes

1

Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))

Measured in %-points.

Time frame
From baseline (week-2-0) to week 22-26
2

Time spent less than (<)3.0 mmol/L (54 mg/dL)

Measured in % of time.

Time frame
From week 22 to week 26
3

Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)

Measured in %-points.

Time frame
From baseline (week-2-0) to week 22-26
4

Number of severe hypoglycaemic episodes (level 3)

Measured as number of episodes.

Time frame
From baseline (week 0) to week 31

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
Apply now