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NCT06083675WithdrawnPhase 3

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Efficacy and Safety of First Line Use of Oral Semaglutide 25 mg or 50 mg Once Daily Versus Empagliflozin 25 mg or Versus Metformin 2000 mg in Newly Diagnosed Treatment naïve Patients With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 26 Feb 2024

Reason given: Due to internal reprioritization, trial was cancelled.

Brief summary (registry, in English)

This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Status (registry)
Withdrawn
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
0 (actual)
First submitted
9 Oct 2023
Start date
26 Jan 2024
Primary completion date
24 Jan 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06083675

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes. Prior insulin treatment for gestational diabetes is allowed.
  • Treatment with any medication for the indication of weight management 90 days prior to screening.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Positive insulinoma associated-protein 2 (IA-2) antibodies ≥7.5 Units/mL or anti-glutamic acid decarboxylase (anti-GAD) antibodies greater than (>) 5.0 international units per milliliter (IU/mL).

Other illness

  • History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
  • Presence of clinically significant gastrointestinal disorders affecting absorption of drugs and/or nutrients, as judged by the investigator.

Lab values

  • Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 meter sqaure (mL/min/1.73 m\^2) at screening.
  • Impaired liver function, defined as Alanine aminotransferase (ALT) ≥2.5 times or Bilirubin >1.5 times upper normal limit at screening.

Other

  • C-peptide <1.5 nanograms per milliliter (ng/mL) at screening.
  • Any contraindications for empagliflozin or metformin according to local labelling at the investigator's discretion

Who the study is looking for

  • Male or female.
  • Age ≥18 and <60 years at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus within 24 months from the day of screening.
  • HbA1c of 7.0-10.0% (53-86 millimoles per mole [mmol/mol])
  • Body mass index ≥25.0 kilogram per square meter (kg/m\^2)

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (100)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.KyustendilBulgariaUnknown status
"Aipsomcemd - Dr. Petya Georgieva" EoodPlovdivBulgariaUnknown status
Diagnostic-Consultative Centre "Sveti Georgi" EoodPlovdivBulgariaUnknown status
''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" EoodSamokovBulgariaUnknown status
"Medical center Medishtit Velisia" OODStara ZagoraBulgariaUnknown status
Diagnostic Consulting Center 1 Velingrad EOODVelingradBulgariaUnknown status
MHAT- Hristo Botev ADVratsaBulgariaUnknown status
Instituto de Ciências FarmacêuticasGoiâniaBrazilUnknown status
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.Porto AlegreBrazilUnknown status
CPQuali Pesquisa Clínica LtdaSão PauloBrazilUnknown status
CPCLIN - Centro de Pesquisas ClínicasSão PauloBrazilUnknown status
Iatriko Psychicou Private ClinicAthensGreeceUnknown status
Laiko General Hospital of AthensAthensGreeceUnknown status
Iatriko Athinon (Athens Medical Canter)AthensGreeceUnknown status
Iatriko Athinon 'Palaiou Falirou'AthensGreeceUnknown status
University Hospital of Athens ATTIKONHaidari-AthensGreeceUnknown status
University General Hospital of Ioannina,Internal MedicineIoanninaGreeceUnknown status
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,DiabetesThessalonikiGreeceUnknown status
General Hospital of Thessaloniki "G. Papanikolaou"ThessalonikiGreeceUnknown status
General Hospital of Thessaloniki G. GennimatasThessalonikiGreeceUnknown status
"Thermi" Private HositalThessalonikiGreeceUnknown status
Opća bolnica KarlovacKarlovacCroatiaUnknown status
Specijalna bolnica Krapinske Toplice - EndokrinologijaKrapinske TopliceCroatiaUnknown status
Poliklinika SLAVONIJA OSIJEKOsijekCroatiaUnknown status
Opca bolnica PulaPulaCroatiaUnknown status
Specijalna Bolnica MedicoRijekaCroatiaUnknown status
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.BudapestHungaryUnknown status
Belinus Bt.DebrecenHungaryUnknown status
Navneeth Memorial HospitalAhmedabadIndiaUnknown status
Swasthya Diabetes CareAhmedabadIndiaUnknown status
Jawahar Lal Nehru Govt. Medical CollegeAjmerIndiaUnknown status
Aligarh Muslim UniversityAligarhIndiaUnknown status
Ramaiah Memorial HospitalBangaloreIndiaUnknown status
Lifecare Hospital and Research CentreBangaloreIndiaUnknown status
Sparsh Hospital, BhubaneshwarBhubaneswarIndiaUnknown status
M.V.Hospital for Diabetes Pvt. Ltd.ChennaiIndiaUnknown status
Maulana Azad Medical CollegeDelhiIndiaUnknown status
Goa Medical CollegeGoaIndiaUnknown status
Endolife Specialty HospitalsGunturIndiaUnknown status
Gandhi Hospital & Medical collegeHyderabadIndiaUnknown status
Osmania General HospitalHyderabadIndiaUnknown status
Yashoda HospitalHyderabadIndiaUnknown status
TOTALL Diabetes Hormone InstituteIndoreIndiaUnknown status
Diabetes, Thyroid and Endocrine CentreJaipurIndiaUnknown status
Excel Endocrine CentreKolhāpurIndiaUnknown status
BP Poddar HospitalKolkataIndiaUnknown status
Medanta Lucknow HospitalLucknowIndiaUnknown status
Dayanand Medical College & Hospital_LudhianaLudhianaIndiaUnknown status
All India Institute of Medical Sciences (AIIMS), NagpurMaharashtraIndiaUnknown status
Seth GS Medical College & KEM HospitalMumbaiIndiaUnknown status
BSES MG hospitalMumbaiIndiaUnknown status
K R HospitalMysuruIndiaUnknown status
JIPMERPuducherryIndiaUnknown status
Lifepoint Multispecialty HospitalPuneIndiaUnknown status
Ashirwad Hospital and Research CentreThaneIndiaUnknown status
Govt Medical CollegeVadodaraIndiaUnknown status
Yalamanchi Hospitals and Research centres pvt ltdVijaywadaIndiaUnknown status
Mahatma Gandhi Memorial Hospital, SherpuraWarangalIndiaUnknown status
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, WardhaWardhaIndiaUnknown status
Medical Care and Research S.A. de C.V.MéridaMexicoUnknown status
Eme Red HospitalariaMéridaMexicoUnknown status
FAICIC S. de R.L. de C.V.VeracruzMexicoUnknown status
Klinik Kesihatan BintuluBintuluMalaysiaUnknown status
Klinik Kesihatan Greentown IpohIpohMalaysiaUnknown status
Klinik Kesihatan Cheras BaruKuala LumpurMalaysiaUnknown status
Hospital MelakaMalaccaMalaysiaUnknown status
Klinik Kesihatan KuangRawangMalaysiaUnknown status
Hospital MiriSarawakMalaysiaUnknown status
Hospital Seri ManjungSeri ManjungMalaysiaUnknown status
Hospital Sultan Haji Ahmad ShahTemerloh,PahangMalaysiaUnknown status
NZOZ Vita-Diabetica Malgorzata BuraczykBialystokPolandUnknown status
Centrum Medyczne INTERCOR Sp. z o.o.BydgoszczPolandUnknown status
Diab Serwis Popenda Spółka JawnaChorzówPolandUnknown status
NZOZ EuromedicaGrudziądzPolandUnknown status
Centra Medyczne Medyceusz Sp. z o.o.LodzPolandUnknown status
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.OlsztynPolandUnknown status
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilnaOpolePolandUnknown status
Trialmed CRSPiotrkow TrybunalskiPolandUnknown status
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska LekarzyPoznańPolandUnknown status
ETG SiedlceSiedlcePolandUnknown status
Clinmedica Research sp. z o.o.SkierniewicePolandUnknown status
Centrum Medyczne OporowWroclawPolandUnknown status
Clinica Grivitei 224 S.R.L.BrăilaRomaniaUnknown status
Diabet Med SRLBucharestRomaniaUnknown status
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion MovilaBucharestRomaniaUnknown status
SC Nutrilife SRLBucharestRomaniaUnknown status
S.C. Dianutrilife Medica S.R.L.PloieştiRomaniaUnknown status
Clinica Korall S.R.L. Satu MareSatu MareRomaniaUnknown status
Sc Mediab SrlTârgu MureşRomaniaUnknown status
Healthcare centre ZvezdaraBelgradeSerbiaUnknown status
Healthcare centre KragujevacKragujevacSerbiaUnknown status
Healthcare centre NisNišSerbiaUnknown status
Ramathibodi HospitalBangkokThailandUnknown status
Rajavithi HospitalBangkokThailandUnknown status
Siriraj HospitalBangkok NoiThailandUnknown status
Maharaj Nakorn Chiang Mai HospitalChiang MaiThailandUnknown status
Srinagarind HospitalKhon KaenThailandUnknown status
Thammasat University HospitalKlong LuangThailandUnknown status
Songklanagarind HospitalSongkhlaThailandUnknown status
Hillcrest Family Health CenterWacoUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.