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Weekly combo shot shows promise for diabetes control

NCT ID NCT05813912

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 3 study tested whether adding semaglutide to a new once-weekly insulin (insulin icodec) improves blood sugar control in 148 adults with type 2 diabetes. Participants first received insulin icodec alone for 26 weeks; those with still-high blood sugar then added semaglutide for another 26 weeks. The main goal was to see how much HbA1c (a measure of blood sugar over time) changed after adding semaglutide.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide and insulin icodec
What this could lead to
If successful, this combination could offer a more effective once-weekly treatment option for people with type 2 diabetes who need better blood sugar control.
What could go wrong
This is a single-arm study with no comparison group, so results may not prove superiority over existing treatments. Side effects like nausea or low blood sugar are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

148 people

The number who actually took part.

Started

Sep 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days prior to the day of screening * HbA1c from 7.5%-10.5% (58-91 millimoles per mole \[mmol/mol\]) (both inclusive) * Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) \>= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses \>= 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, alpha-glucosidase inhibitors. Oral combination products (for the allowed individual oral anti-diabetic drugs) Exclusion Criteria: * Presence or history of pancreatitis (acute or chronic) within 180 days before screening * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening * Planned coronary, carotid or peripheral artery revascularization * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000, Serbia

  • Centrum Badan Klinicznych PI-House Sp. z o.o.

    Gdansk, 80-546, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081, Poland

  • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

    Novi Sad, Vojvodina, 21000, Serbia

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000, Serbia

  • Clinical Hospital Centre Zemun

    Belgrade, 11080, Serbia

  • Comfort Care Praha s.r.o.

    Praha 4 - Chodov, 148 00, Czechia

  • DIALINE s.r.o.

    Plzeň 3, 301 00, Czechia

  • DIAMIN

    Chrudim, 537 01, Czechia

  • DiaPodi care s.r.o.

    Soběslav I, 39201, Czechia

  • Diabet2 s.r.o.

    Prague, 110 00, Czechia

  • Diabetologická a endokrinologická ambulance Praha

    Prague, 140 21, Czechia

  • Diabetologické centrum s.r.o.

    Olomouc, 779 00, Czechia

  • EUC Klinika Praha a.s.

    Prague, 150 00, Czechia

  • Edumed Broumov

    Broumov, 550 01, Czechia

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000, Malaysia

  • Hospital Miri

    Miri, Sarawak, 98000, Malaysia

  • Hospital Putrajaya

    Putrajaya, Putrajaya, 62250, Malaysia

  • Hospital Seri Manjung

    Seri Manjung, Perak, 32040, Malaysia

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

    Krakow, Lesser Poland Voivodeship, 31-261, Poland

  • Medicon a.s.

    Prague, 140 00, Czechia

  • Metabolica Sp. z o.o.

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • NBR Polska

    Warsaw, Masovian Voivodeship, 00-710, Poland

  • NBR Polska Tomasz Klodawski

    Warsaw, 00-710, Poland

  • NZOZ Gdanska Poradnia Cukrzycowa

    Gdansk, 80-858, Poland

  • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

    Gdansk, 80-858, Poland

  • Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Osteo-Medic s.c. A. Racewicz, J. Supronik

    Bialystok, 15-351, Poland

  • Poradnia Chorob Metabolicznych w Wierzchoslawicach

    Wierzchosławice, 33-122, Poland

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Rajavithi Hospital_Diabetes and Endocrinology

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital - Ped-Endo and Metabolism

    Bangkok, 10400, Thailand

  • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302, Poland

  • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, Łódź Voivodeship, 90-302, Poland

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzów Wielkopolski, 66-400, Poland

  • Universiti Teknologi MARA, Sungai Buloh Campus

    Sungai Buloh, Selangor, 47000, Malaysia

  • Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu

    Zabrze, 41-800, Poland

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