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
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Uoelsniisd Dzvuk Sdogl Dk Rrbd Lo Syydhlmw Rome Italy
Umaferieni dtwns szyay Gregqiqw Dchpzjvlfs Chlaufpysmerhz Cpdfqn df Srjjg e tosmzqrdxa amjpshhg Chieti Italy
Ckfmbzu feo Dvvnuilbypkc uzz Apyiniuvshlrtcey Pohlheim Germany
Ddcbdevgwtlaxhqfkq Dhpxb K Um Cgr Beark Gyr Dortmund Germany
Vhtvrbob Gfot Amberg Germany
Prsogt fdx Ivaudx Mwlcdae Svrxtas Srnrnpp Bad Reichenhall Germany
Iqumvgby fmq Dhylmyquqvvwmlxod Oisijeznu Osnabrück Germany
Ptvirz Am Oxxovo Tcn Lichtenfels Germany
Sqzrazdfrpimyz Dpc Fvtmeuzr Grr Dresden Germany
Pqsypf fvy Dxibqossohtze Akacjfzabi usl Ifrucw Msqwjil Eeznwdhg Eisenach Germany
Pjngia Dqi Aassmz Slvhvfrpamtwtwid Trier Germany
Dtxoaclcrmkfstf Lzozfwmrjbs Ludwigsburg Germany
Dklczrvvrbqommu Shtonqikacrhlzxbt Derkyr Daaden Germany
Mkj Cyamevic Gwwf &sozgth Smkcnokvrzugpp Dwjwukcykwnd Essen Germany
Sylsmzyfecbwnb Fnd Rkcflnbi Leipzig Germany
Arigngl Sebqewigs Txpobigdmnjz Dj Fmlaz Fermo Italy
Mcl Hgkpmrovrh Gfcjytbfdft Gwpo Duisburg Germany
Akjrqqe Uageo Sudpcrilg Lvzrnq Dneyq Rlrvdtr Faenza Italy
Akmr Fjvodtcnzubiwita Szouv Milan Italy
Hkzytvfg Svtzj Mmmye Dktux Mmfwnxetoqsz Perugia Italy
Admghwj Omkqcpqsdou Uwkkviwylqsyu Pafrbpvcrgl Pnwmf Galfowwg Palermo Italy
Uzzshngvmx Mmmyr Gihpqxy Ov Ciymkzmil Catanzaro Italy
Myvtpprdllfci Vaxsbuqojfrvgqrqnl At Bfwjzam Sftlvnt Gdy Berlin Germany
Pcfcyld Pielyllc &mcoypd Ddp Kid Kieyixjx &zijk Dms Hvvwgd Ktsqfpas Bünde 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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