Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
NCT ID: NCT05552859
Last Updated: 2025-09-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
62 participants
INTERVENTIONAL
2022-12-05
2023-08-04
Brief Summary
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Detailed Description
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* A screening period of up to 2 weeks,
* A 24-week, open-label treatment period, including a titration period and a maintenance period.
* A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gla-300 arm
Gla-300 will be administered once daily for 24 weeks
Insulin glargine 300 U/mL
Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
IDeg-100 arm
Ideg-100 will be administered once daily for 24 weeks
Insulin degludec 100 U/mL
Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.
Interventions
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Insulin glargine 300 U/mL
Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
Insulin degludec 100 U/mL
Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Yuma Clinical Trials, LLC Site Number: 8400028
Yuma, Arizona, United States
American Clinical Trials Site Number: 8400014
Buena Park, California, United States
Clearview Medical Research LLC Site Number: 8400021
Canyon Country, California, United States
Torrance Clinical Research Institute Site Number: 8400003
Lomita, California, United States
Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026
Santa Clarita, California, United States
San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023
Van Nuys, California, United States
Chase Medical Research LLC Site Number: 8400007
Waterbury, Connecticut, United States
Innovative Research of West Florida Site Number: 8400016
Clearwater, Florida, United States
Evolution Clinical Trials Site number: 8400034
Hialeah Gardens, Florida, United States
Wellness Research Center Inc - Miami Site Number: 8400010
Miami, Florida, United States
Med Research of Florida, LLC Investigator Site: 8400033
Miami, Florida, United States
Florida Institute For Clinical Research LLC Site Number: 8400004
Orlando, Florida, United States
Emory University Site Number: 8400032
Atlanta, Georgia, United States
Agile Clinical Research Trials, LLC Site Number: 8400001
Atlanta, Georgia, United States
Centricity Research Site Number: 8400006
Columbus, Georgia, United States
Georgia Clinical Research Site Number: 8400009
Lawrenceville, Georgia, United States
Endocrine and Metabolic Consultants Research Center Site Number: 8400031
Rockville, Maryland, United States
Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019
Las Vegas, Nevada, United States
Mid Hudson Medical Research PLLC Site Number: 8400024
New Windsor, New York, United States
Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008
Morehead City, North Carolina, United States
Advanced Medical Research Site Number: 8400012
Maumee, Ohio, United States
Capital Area Research LLC Site Number: 8400029
Newport, Pennsylvania, United States
Jefferson University Physicians (JUP) Site Number: 8400025
Philadelphia, Pennsylvania, United States
Holston Medical Group PC Site Number: 8400018
Bristol, Tennessee, United States
Frontier Medical Center Site Number: 8400035
El Paso, Texas, United States
Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015
Fort Worth, Texas, United States
Juno Research, LLC Site Number: 8400017
Houston, Texas, United States
Reichman and Associates Site Number: 8400013
Houston, Texas, United States
Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027
Lufkin, Texas, United States
Northeast Clinical Research of San Antonio LLC Site Number: 8400022
Schertz, Texas, United States
Consano Clinical Research Site Number: 8400030
Shavano Park, Texas, United States
David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005
Suffolk, Virginia, United States
Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001
Krnov, Moravskoslezský kraj, Czechia
Agentura Science Pro spol. s.r.o.Site Number: 2030002
Olomouc, Olomoucký kraj, Czechia
Institut Klinicke A Experimentalni Mediciny Site Number: 2030006
Prague, Praha, Hlavní Mesto, Czechia
Diacentrum Brandys n. L. Site Number: 2030004
Brandýs nad Labem-Stará Boleslav, , Czechia
Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005
Jílové u Prahy, , Czechia
Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007
Prague, , Czechia
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Markusovszky Egyetemi Oktatókórház Site Number: 3480001
Szombathely, Vas County, Hungary
Csolnoky Ferenc Korhaz Site Number: 3480005
Balatonfüred, Veszprém megye, Hungary
Zala Megyei Szent Rafael Korhaz Site Number: 3480002
Zalaegerszeg, Zala County, Hungary
Magyar Honvédség Egészségügyi Központ Site Number: 3480003
Budapest, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004
Kaposvár, , Hungary
Centrum Medyczne OMEDICA Site Number: 6160013
Poznan, Greater Poland Voivodeship, Poland
Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016
Krakow, Lesser Poland Voivodeship, Poland
Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009
Wroclaw, Lower Silesian Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008
Lublin, Lublin Voivodeship, Poland
KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010
Puławy, Lublin Voivodeship, Poland
KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012
Zamość, Lublin Voivodeship, Poland
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015
Radom, Masovian Voivodeship, Poland
NBR Polska Site Number: 6160003
Warsaw, Masovian Voivodeship, Poland
Centralny Szpital Kliniczny MSW Site Number: 6160005
Warsaw, Masovian Voivodeship, Poland
NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014
Gdansk, Pomeranian Voivodeship, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001
Częstochowa, Silesian Voivodeship, Poland
Specjalistyczna Praktyka Lekarska Site Number: 6160004
Lubliniec, Silesian Voivodeship, Poland
ETG Lodz Site Number: 6160018
Lodz, , Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017
Lódz, , Poland
Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014
Poznan, , Poland
Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002
Radom, , Poland
ETG Skierniewice - PPDS Site Number: 6160006
Skierniewice, , Poland
KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011
Staszów, Świętokrzyskie Voivodeship, Poland
Clinical Hospital Centar Zvezdara Site Number: 6880001
Belgrade, , Serbia
University Clinical Center of Serbia - PPDS Site Number: 6880003
Belgrade, , Serbia
University Clinical Center of Serbia - PPDS Site Number: 6880004
Belgrade, , Serbia
University Clinical Center Nis Site Number: 6880002
Niš, , Serbia
University Clinical Center Nis Site Number: 6880005
Niš, , Serbia
Health Center Zajecar Site Number: 6880006
Zaječar, , Serbia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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LPS17007 Plain Language Results Summary
Other Identifiers
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2022-001485-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LPS17007
Identifier Type: -
Identifier Source: org_study_id
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