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Comparing weekly insulin icodec and daily insulin glargine with insulin aspart in adults with type 1 diabetes: a 26-week study of blood sugar control

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on adults with Type 1 Diabetes, a condition where the body does not produce insulin naturally, requiring daily insulin injections to control blood sugar levels. The study will compare two different insulin treatments: a new once-weekly insulin called insulin icodec and a standard once-daily insulin glargine. Both treatments will be used in combination with insulin aspart, which is taken at mealtimes to control blood sugar.

The purpose of this research is to evaluate how well the weekly insulin icodec controls blood sugar levels compared to daily insulin glargine in people with Type 1 Diabetes. The study will use pre-filled injection pens called FlexTouch to deliver the insulin medications under the skin. Participants will receive either weekly insulin icodec or daily insulin glargine for 26 weeks.

During the study, blood sugar control will be monitored through various measurements, including HbA1c (a blood test that shows average blood sugar levels over the past few months) and continuous glucose monitoring using a device called Dexcom G7. The study will also track other important factors such as the number of low blood sugar episodes and changes in body weight.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    The study will last for 26 weeks and compare two different insulin treatments for type 1 diabetes.

    You will be assigned to receive either once-weekly insulin icodec (Awiqli 700 units/mL) or once-daily insulin glargine (Lantus SoloStar 100 units/mL).

    Both treatments will be combined with insulin aspart for meal-time insulin needs.

    The medications will be administered by injection under the skin (subcutaneous injection).

  2. Step 2

    Blood sugar monitoring

    Your blood sugar levels will be monitored using a continuous glucose monitoring system (Dexcom G7).

    You will need to perform regular self-measured blood glucose tests according to the provided schedule.

    The main measurement will be your HbA1c level (a test that shows your average blood sugar over the past 2-3 months).

  3. Step 3

    Regular assessments

    Your total weekly insulin dose will be tracked throughout the study.

    Changes in body weight will be monitored.

    You will complete questionnaires about your treatment satisfaction.

    Any episodes of low blood sugar (hypoglycemia) will be recorded and classified by severity.

  4. Step 4

    Study completion

    After 26 weeks, final measurements will be taken to evaluate the effectiveness of the treatment.

    The main goal is to compare how well both treatments control blood sugar levels.

    The study will assess if weekly insulin is as effective as daily insulin for treating type 1 diabetes.

Who can join the trial?

8 criteria

  • Have been diagnosed with type 1 diabetes for at least 1 year before the study begins
  • Currently using multiple daily insulin injections (both long-acting basal insulin and short-acting mealtime insulin) for at least 6 months before the study begins
  • Have a HbA1c level (a blood test that measures average blood sugar over the past 3 months) between 7.0% and 10.0% at the initial screening visit
  • Be willing and able to:
    • Follow the study protocol
    • Perform regular blood glucose measurements at home using a glucose meter
    • Attend all required study visits
    • Be an adult (18 years or older)
    • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Not diagnosed with Type 1 Diabetes
  • Currently pregnant or breastfeeding women
  • Previous severe allergic reactions to insulin medications
  • Inability to perform regular blood sugar monitoring
  • Severe kidney problems (chronic kidney disease)
  • Severe liver problems (liver dysfunction)
  • History of recurrent severe low blood sugar episodes (hypoglycemia)
  • Active cancer or undergoing cancer treatment
  • Major surgery in the past 3 months
  • Participation in other clinical trials within the past 30 days
  • Unstable heart conditions
  • Mental conditions that could interfere with following study procedures
  • Alcohol or drug abuse within the past 12 months
  • Using medications that significantly interact with insulin
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Investigated drugs

  • Insulin icodec

    is a new type of long-acting insulin that is taken once a week. It helps control blood sugar levels over a longer period compared to traditional daily insulin. It works by slowly releasing insulin into the bloodstream throughout the week.

  • Insulin glargine

    is a long-acting insulin that is taken once daily. It provides background insulin throughout the day and night to help maintain stable blood sugar levels between meals and during sleep.

  • Insulin aspart

    is a fast-acting insulin that is taken at mealtimes. It works quickly to control blood sugar levels that rise after eating. It's commonly used in combination with longer-acting insulins to provide complete diabetes management.

What is already known about the treatment

  • Insulin Icodec

    A novel once-weekly injectable insulin medication currently being investigated for Type 1 Diabetes treatment. This long-acting insulin analog represents a significant advancement in diabetes care by allowing weekly rather than daily administration, working by steadily releasing insulin into the bloodstream to control blood glucose levels. The medication belongs to the class of basal insulin analogs and is being studied in combination with insulin aspart for complete diabetes management.

  • Insulin Glargine U100

    A long-acting insulin medication administered once daily via subcutaneous injection for treating Type 1 Diabetes. This synthetic insulin analog provides steady, 24-hour blood glucose control by forming micro-precipitates in subcutaneous tissue, allowing for gradual absorption into the bloodstream. It belongs to the basal insulin analog class and is commonly used in combination with rapid-acting insulin like insulin aspart for comprehensive diabetes management.

  • Insulin Aspart

    A rapid-acting insulin analog administered via subcutaneous injection before meals for Type 1 Diabetes management. This medication works by quickly lowering blood glucose levels after meals, mimicking the body's natural insulin response to food intake. It belongs to the class of rapid-acting insulin analogs and is designed to be used in combination with long-acting insulin for complete daily glucose control.

Investigated diseases

Type 1 Diabetes - A chronic autoimmune condition where the body's immune system attacks and destroys insulin-producing cells in the pancreas. This disease typically develops in childhood or adolescence, but can occur at any age. The body becomes unable to produce insulin, which is necessary for moving glucose from the bloodstream into cells for energy. Without insulin production, blood sugar levels rise abnormally high, leading to various symptoms including increased thirst, frequent urination, and fatigue. The condition causes the body to break down fats and proteins for energy instead of using glucose, which can lead to weight loss and other metabolic changes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519945-31-00Protocol codeNN1436-8182Estimated enrolment877 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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