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Comparison of weekly insulin icodec versus daily basal insulin in adults with type 2 diabetes who have not used insulin before

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 study looks at how well a new weekly insulin called insulin icodec works compared to daily insulin treatments in people with Type 2 diabetes. The study will compare Awiqli, which contains insulin icodec, to other long-acting insulins like Tresiba, Lantus, Toujeo, and Levemir. These medications are given as injections under the skin.

The purpose is to see if taking insulin once a week works as well as taking it once a day for controlling blood sugar levels. The study will measure how well both treatments control blood sugar by checking HbA1c levels (a measure of average blood sugar) over 52 weeks. The medications will be given through pre-filled injection pens that patients can use at home.

During the study, participants will continue taking their other diabetes medications while adding either the weekly or daily insulin. The study will also look at how satisfied patients are with their treatment and how well they stick to their prescribed insulin schedule. Researchers will monitor participants for side effects, particularly episodes of very low blood sugar.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your blood sugar control will be measured through a HbA1c test. This test shows your average blood sugar levels over the past 3 months.

    Your current diabetes medications will be reviewed to ensure they meet the study requirements.

  2. Step 2

    Treatment assignment

    You will be assigned to receive either:

    Weekly insulin icodec (Awiqli 700 units/mL) - given once per week through an injection under the skin using a pre-filled pen

    OR

    Daily basal insulin (various types) - given once per day through an injection under the skin using either a pre-filled pen, cartridge, or vial

  3. Step 3

    Treatment period

    The treatment period lasts for 52 weeks (one year)

    You will continue using your current non-insulin diabetes medications

    You will need to monitor your blood sugar levels regularly

    The insulin dose may be adjusted based on your blood sugar readings

  4. Step 4

    Follow-up visits

    Regular check-ups will occur throughout the 52-week period

    Your HbA1c will be measured to track your blood sugar control

    You will complete questionnaires about your treatment experience

    Any episodes of very low blood sugar (severe hypoglycemia) will be recorded

  5. Step 5

    Final assessment

    After 52 weeks, your final HbA1c test will be performed

    Your insulin doses will be recorded

    You will complete final questionnaires about your treatment satisfaction and experience

Who can join the trial?

13 criteria

  • Have been diagnosed with Type 2 diabetes for at least 180 days before screening
  • Currently taking one or more of these diabetes medications:
    • Metformin (a common diabetes pill)
    • Sulfonylureas (medications that help your body release more insulin)
    • Meglitinides (medications that help control blood sugar after meals)
    • DPP-4 inhibitors (pills that help control blood sugar levels)
    • SGLT2 inhibitors (medications that help remove excess sugar through urine)
    • Thiazolidinediones (medications that help your body use insulin better)
    • Alpha-glucosidase inhibitors (medications that slow down digestion of carbohydrates)
    • GLP-1 receptor agonists (medications that help control blood sugar, can be pills or injections)
    • Need to start using insulin treatment, as determined by your doctor
    • Have a HbA1c (blood test that measures average blood sugar over 3 months) level of 7% or higher within the last 90 days
    • Can be either male or female
    • Must be an adult (18 years or older)

Who cannot join the trial?

16 criteria

  • Age below 18 years or above 75 years
  • Previous treatment with any type of insulin in the past 6 months
  • Known or suspected allergy to insulin or any components of the study medications
  • Severe liver problems (liver disease)
  • Severe kidney problems (renal impairment)
  • History of pancreatitis (inflammation of the pancreas)
  • Current pregnancy or breastfeeding
  • Planning to become pregnant during the study period
  • Participation in another clinical trial within the last 30 days
  • History of alcohol or drug abuse within the past 12 months
  • Major surgery planned during the study period
  • Active cancer or cancer treatment within the past 5 years
  • History of severe hypoglycemia (very low blood sugar) in the past 12 months
  • Unstable heart disease or recent heart attack (within past 6 months)
  • Mental condition that could interfere with study participation
  • Unable to perform regular blood glucose monitoring
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Investigated drugs

  • Insulin icodec

    This is a new type of long-acting insulin that is injected once a week. It helps control blood sugar levels in people with type 2 diabetes who haven't used insulin before. This medication is designed to make insulin treatment more convenient by reducing the number of injections needed from daily to weekly.

  • Basal insulin analogues

    These are long-acting insulin medications that are injected once daily. They work by providing a steady level of insulin throughout the day and night to help control blood sugar levels in people with type 2 diabetes. These are commonly used insulin products that help maintain baseline blood sugar control.

What is already known about the treatment

  • Insulin icodec

    A novel once-weekly basal insulin analog developed for type 2 diabetes treatment, administered through subcutaneous injection. This long-acting insulin is currently being studied in clinical trials as a potential alternative to daily insulin injections, representing a significant advancement in diabetes care. The medication works by slowly releasing insulin into the bloodstream over seven days, helping to control blood sugar levels by enabling cells to absorb glucose from the blood, while its unique molecular structure allows for the extended release profile. It belongs to the class of long-acting insulin analogs and is being investigated as a more convenient option for insulin-naive patients with type 2 diabetes who require basal insulin therapy.

  • Basal insulin analogues

    A group of long-acting insulin medications administered once daily via subcutaneous injection for the treatment of type 2 diabetes. These medications provide a steady background level of insulin throughout the day, mimicking the body's natural basal insulin production. They work by helping cells absorb glucose from the bloodstream, thereby controlling blood sugar levels over an extended period, typically 24 hours. These insulin analogues belong to the class of long-acting insulins and are commonly used as a first insulin therapy option for patients with type 2 diabetes when oral medications alone are no longer sufficient for glycemic control.

Investigated diseases

Type 2 Diabetes - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition typically develops gradually, often beginning with insulin resistance where body cells don't respond effectively to insulin. As the disease progresses, the pancreas may produce less insulin, leading to increased blood glucose levels. Common symptoms include increased thirst, frequent urination, fatigue, blurred vision, and slow-healing wounds. The condition is often associated with lifestyle factors and tends to appear in adults, though it can develop at any age.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520068-32-00Protocol codeNN1436-7727Estimated enrolment510 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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