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Insulin showdown: toujeo vs tresiba for diabetics with kidney disease

NCT ID NCT05552859

Disease control Sponsor: Sanofi 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compared two long-acting insulins, Toujeo and Tresiba, in people with type 2 diabetes who also have kidney problems and had never used insulin before. The goal was to see which one controls blood sugar better and causes fewer low blood sugar events. The trial was stopped early and included only 62 participants, so the findings are not conclusive.

What this could mean

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

Active substance
Insulin glargine 300 U/mL (Toujeo) and insulin degludec 100 U/mL (Tresiba)
What this could lead to
If successful, this could show that one insulin works better or is safer for people with diabetes and kidney disease.
What could go wrong
The trial was terminated early with only 62 participants, so results are limited. It was also open-label, meaning both patients and doctors knew which insulin was given, which can bias results.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

62 people

The number who actually took part.

Started

Dec 2022

Finished

Aug 2023

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: 1. Is an adult aged ≥18 years at screening. 2. Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of \>1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period. 3. Has an HbA1c ≥7.5% and ≤10.5% at screening. 4. Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of \<60 mL/min/1.73m2 and ≥15 mL/min/1.73m2. 5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion. 6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period. 7. Is capable of understanding the written informed consent, and provides signed written informed consent. 8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements. 9. Is willing and able to fast without having administered study drug for scheduled site visits. Exclusion Criteria: 1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA. 2. Has a body mass index (BMI)\* \>45 kg/m² during the screening period. 3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms \[eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion\] or as the failure to sense a significant fall in blood glucose below normal levels). 4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening. 5. Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

impaired renal function disease kidney failure type 2 diabetes mellitus

As listed by the trial registrant

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

Renal impairment Type 2 diabetes mellitus

Contacts and locations

Locations

  • Advanced Medical Research Site Number: 8400012

    Maumee, Ohio, 43537-1863, United States

  • Agentura Science Pro spol. s.r.o.Site Number: 2030002

    Olomouc, Olomouc Region, 779 00, Czechia

  • Agile Clinical Research Trials, LLC Site Number: 8400001

    Atlanta, Georgia, 30328-5532, United States

  • American Clinical Trials Site Number: 8400014

    Buena Park, California, 90620-3800, United States

  • Capital Area Research LLC Site Number: 8400029

    Newport, Pennsylvania, 17074, United States

  • Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026

    Santa Clarita, California, 91321-2454, United States

  • Centralny Szpital Kliniczny MSW Site Number: 6160005

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Centricity Research Site Number: 8400006

    Columbus, Georgia, 31904, United States

  • Centrum Medyczne OMEDICA Site Number: 6160013

    Poznan, Greater Poland Voivodeship, 60-111, Poland

  • Chase Medical Research LLC Site Number: 8400007

    Waterbury, Connecticut, 06708, United States

  • Clearview Medical Research LLC Site Number: 8400021

    Canyon Country, California, 91351-4138, United States

  • Clinical Hospital Centar Zvezdara Site Number: 6880001

    Belgrade, 11000, Serbia

  • Consano Clinical Research Site Number: 8400030

    Shavano Park, Texas, 78231, United States

  • Csolnoky Ferenc Korhaz Site Number: 3480005

    Balatonfüred, Veszprém megye, 8230, Hungary

  • David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005

    Suffolk, Virginia, 23435-3763, United States

  • Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015

    Fort Worth, Texas, 76132-4242, United States

  • Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019

    Las Vegas, Nevada, 89113-3628, United States

  • Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005

    Jílové u Prahy, 254 00, Czechia

  • Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001

    Krnov, Moravian-Silesian Region, 794 01, Czechia

  • Diacentrum Brandys n. L. Site Number: 2030004

    Brandýs nad Labem-Stará Boleslav, 250 01, Czechia

  • ETG Lodz Site Number: 6160018

    Lodz, 90-302, Poland

  • ETG Skierniewice - PPDS Site Number: 6160006

    Skierniewice, Lódzkie, Poland

  • Emory University Site Number: 8400032

    Atlanta, Georgia, 30303, United States

  • Endocrine and Metabolic Consultants Research Center Site Number: 8400031

    Rockville, Maryland, 20852, United States

  • Evolution Clinical Trials Site number: 8400034

    Hialeah Gardens, Florida, 33016, United States

  • Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007

    Prague, 100 34, Czechia

  • Florida Institute For Clinical Research LLC Site Number: 8400004

    Orlando, Florida, 32825, United States

  • Frontier Medical Center Site Number: 8400035

    El Paso, Texas, 79935-4202, United States

  • Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017

    Lódz, 90-132, Poland

  • Georgia Clinical Research Site Number: 8400009

    Lawrenceville, Georgia, 30044-5896, United States

  • Health Center Zajecar Site Number: 6880006

    Zaječar, 19000, Serbia

  • Holston Medical Group PC Site Number: 8400018

    Bristol, Tennessee, 37620-7353, United States

  • Innovative Research of West Florida Site Number: 8400016

    Clearwater, Florida, 33756-2004, United States

  • Institut Klinicke A Experimentalni Mediciny Site Number: 2030006

    Prague, Praha, Hlavní Mesto, 140 21, Czechia

  • Jefferson University Physicians (JUP) Site Number: 8400025

    Philadelphia, Pennsylvania, 19107-6810, United States

  • Juno Research, LLC Site Number: 8400017

    Houston, Texas, 77054, United States

  • KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010

    Puławy, Lublin Voivodeship, 24-100, Poland

  • KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012

    Zamość, Lublin Voivodeship, 22-400, Poland

  • KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011

    Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

  • Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008

    Morehead City, North Carolina, 28557-3126, United States

  • Magyar Honvédség Egészségügyi Központ Site Number: 3480003

    Budapest, 1134, Hungary

  • Markusovszky Egyetemi Oktatókórház Site Number: 3480001

    Szombathely, Vas County, 9700, Hungary

  • Med Research of Florida, LLC Investigator Site: 8400033

    Miami, Florida, 33186, United States

  • Mid Hudson Medical Research PLLC Site Number: 8400024

    New Windsor, New York, 12553-7754, United States

  • NBR Polska Site Number: 6160003

    Warsaw, Masovian Voivodeship, 00-465, Poland

  • NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014

    Gdansk, Pomeranian Voivodeship, 80-858, Poland

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001

    Częstochowa, Silesian Voivodeship, 42-207, Poland

  • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008

    Lublin, Lublin Voivodeship, 20-538, Poland

  • Northeast Clinical Research of San Antonio LLC Site Number: 8400022

    Schertz, Texas, 78154-1403, United States

  • Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014

    Poznan, 61-655, Poland

  • Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015

    Radom, Masovian Voivodeship, 26-610, Poland

  • Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002

    Radom, 26-600, Poland

  • Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009

    Wroclaw, Lower Silesian Voivodeship, 50-127, Poland

  • Reichman and Associates Site Number: 8400013

    Houston, Texas, 77074-1691, United States

  • San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023

    Van Nuys, California, 91405-3605, United States

  • Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004

    Kaposvár, 7400, Hungary

  • Specjalistyczna Praktyka Lekarska Site Number: 6160004

    Lubliniec, Silesian Voivodeship, 42-700, Poland

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027

    Lufkin, Texas, 75904-3163, United States

  • Torrance Clinical Research Institute Site Number: 8400003

    Lomita, California, 90717-2101, United States

  • University Clinical Center Nis Site Number: 6880002

    Niš, 18 000, Serbia

  • University Clinical Center Nis Site Number: 6880005

    Niš, 18 000, Serbia

  • University Clinical Center of Serbia - PPDS Site Number: 6880003

    Belgrade, 11000, Serbia

  • University Clinical Center of Serbia - PPDS Site Number: 6880004

    Belgrade, 11000, Serbia

  • Wellness Research Center Inc - Miami Site Number: 8400010

    Miami, Florida, 33135-1601, United States

  • Yuma Clinical Trials, LLC Site Number: 8400028

    Yuma, Arizona, 85364-7110, United States

  • Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016

    Krakow, Lesser Poland Voivodeship, 31-548, Poland

  • Zala Megyei Szent Rafael Korhaz Site Number: 3480002

    Zalaegerszeg, Zala County, 8904, Hungary

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