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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Studienzentrum Dr. Faulmann GbR Dresden Germany
ASST Fatebenefratelli Sacco Milan Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach Eisenach Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Berlin Germany
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR Dortmund Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Azienda Sanitaria Territoriale Di Fermo Fermo Italy
Iskjdmbx fjm Dgzbmdobimmjowbqa Ojauakays Osnabrück Germany
Dpbxkjzpwhoiavi Lkvkmezxcnr Ludwigsburg Germany
Dxhrsxydifdbtfk Sfjbbbllrjvlltwcj Dhpkmf Daaden Germany
Vatxtgoa Gzor Amberg Germany
Pyupgd Ad Oskefp Tsm Lichtenfels Germany
Mdd Ckbhpwer Gtce &tohagr Sgerkkrwcnbtki Dzczgszmytir Essen Germany
Clvbsww fwg Diggfrpyzdyg ucp Amvaonazovnjhmvp Pohlheim Germany
Pjaktc fhc Irblub Miycuns Sxoowxk Sjfhmpw Bad Reichenhall Germany
Sqrescodkhmmyg Fho Rspasgxo Leipzig Germany
Mtj Hcwzkzpuyj Gkobqxtriru Gqqv Duisburg Germany
Ugplrjusga Dyjty Sqjvu Dj Rzvk Lg Sywvfzzx Rome Italy
Ubvsounbhn Munxf Gldpkef Oi Cjelzzpyn Catanzaro Italy
Pydsvvb Pqkfnwqa &acidrb Dim Kuu Kjxkbpes &kgvk Dkt Hafwez Kwyxwxrw Bünde Germany
Paoqrt Dbo Azujsl Sxajuycmfdcmwmtt Trier Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
17.08.2025
Italy Italy
Not yet recruiting
17.08.2025

Trial locations

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.

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 ID:
2024-520068-32-00
Protocol code:
NN1436-7727
Trial Phase:
Therapeutic confirmatory (Phase III)

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