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

3 1 1 1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
GABINET LEKARSKI MALGORZATA SARYUSZ-WOLSKA Lodz Poland
MVZ DiaMedicum Bad Mergentheim GmbH Bad Mergentheim Germany
Diabetes-Zentrum-Wilhelmsburg GbR Hamburg Germany
Ośrodek Badań Klinicznych “METABOLICA” lek. Robert Witek Tarnow Poland
Diabeteszentrum Hamburg West Hamburg Germany

Other Sites

Site Name City Country Status
Zanamed Medical Clinic Sp. z o.o. Lublin Poland
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Nutrilife S.R.L. Bucharest Romania
Clinica Korall S.R.L. Satu Mare Romania
Reumed Sp. z o.o. Lublin Poland
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j. Legnica Poland
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j. Piotrkow Trybunalski Poland
Diabeda s.r.o. Bratislava Slovakia
Medispektrum s.r.o. Petrzalka Slovakia
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach Eisenach Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Berlin Germany
InnoDiab Forschung GmbH Essen Germany
Sc Cmi Dr. Pletea Noemi S.R.L. Bacau Romania
Diamed Obesity S.R.L. Galati Romania
Diabint s.r.o. Bytca Slovakia
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Cracow Poland
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Human-Care s.r.o. Kosice Slovakia
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o. Poznan Poland
MVZ Diabeteszentrum Dr. Tews GmbH Gelnhausen Germany
Zentrum für klinische Forschung Allgäu Oberschwaben Wangen Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Munster Germany
DSP Diabetes- und Stoffwechselpraxis Bochum Bochum Germany
Die Praxis am Ludwigsplatz Ludwigshafen Am Rhein Germany
Zentrum für klinische Studien Alexander Segner St. Ingbert Germany
Mheyybl Skjcno Bacau Romania
Fbtsjp 2 Shu z ovsn Oświęcim Poland
Caaxtoo Madimgi Dq Dkjlzwteay Sl Tdfshcjwi Aybroodww Nqlvlt Sumisl Brasov Romania
Ipcucasr fvk Dbctldvyplkpagwba Olljqfltp Osnabrück Germany
Darhixavzdex Mfyrvo Sawijf Ploiesti Romania
Twj Dbqaes Sxriou Craiova Romania
Dvunwbjpdqwnimyrjze Sfragf Bucharest Romania
Daoxss sojlyr Knvmle Kosice Slovakia
Zgjadp Wzqjeetxvbis Pqrfgldntu Sqbizfzcyvkyuhbck w Koqghehcyt Zabrze Poland
Dcnrxwha Zrqzucz Wjgehmmk Dwsnasombtprvfc Srjsjqftdnfgzxcae Blsiylzevzqhyfgilpwsegyrodnx Gpa Hamburg Germany
Dhmzu svqgdu Kosice Slovakia
Ewl Zxmska Zamosc Poland
Pxlaseega Inigiaty Mlrxqsgy Metnhdusgpzt Surtd Wigdwwtxtmwy I Ahnhwivobswoo Warsaw Poland
Ddexujf Dul Pjdweco Aybqvwiefoe Szaaza Ploiesti Romania

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
22.08.2025
Poland Poland
Recruiting
22.08.2025
Romania Romania
Recruiting
22.08.2025
Slovakia Slovakia
Recruiting
22.08.2025

Trial locations

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.

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 ID:
2024-519945-31-00
Protocol code:
NN1436-8182
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Colchicine to Reduce Complications in People with Type 1 Diabetes and High Blood Sugar Variability

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Using glucagon and automated insulin delivery to prevent low blood sugar during exercise in adults with type 1 diabetes

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark