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- Withdrawn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
- Diseases
- Type 2 diabetes
- 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
Sites (100)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd. | Kyustendil | Bulgaria | Unknown status |
| "Aipsomcemd - Dr. Petya Georgieva" Eood | Plovdiv | Bulgaria | Unknown status |
| Diagnostic-Consultative Centre "Sveti Georgi" Eood | Plovdiv | Bulgaria | Unknown status |
| ''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood | Samokov | Bulgaria | Unknown status |
| "Medical center Medishtit Velisia" OOD | Stara Zagora | Bulgaria | Unknown status |
| Diagnostic Consulting Center 1 Velingrad EOOD | Velingrad | Bulgaria | Unknown status |
| MHAT- Hristo Botev AD | Vratsa | Bulgaria | Unknown status |
| Instituto de Ciências Farmacêuticas | Goiânia | Brazil | Unknown status |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. | Porto Alegre | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Ltda | São Paulo | Brazil | Unknown status |
| CPCLIN - Centro de Pesquisas Clínicas | São Paulo | Brazil | Unknown status |
| Iatriko Psychicou Private Clinic | Athens | Greece | Unknown status |
| Laiko General Hospital of Athens | Athens | Greece | Unknown status |
| Iatriko Athinon (Athens Medical Canter) | Athens | Greece | Unknown status |
| Iatriko Athinon 'Palaiou Falirou' | Athens | Greece | Unknown status |
| University Hospital of Athens ATTIKON | Haidari-Athens | Greece | Unknown status |
| University General Hospital of Ioannina,Internal Medicine | Ioannina | Greece | Unknown status |
| EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes | Thessaloniki | Greece | Unknown status |
| General Hospital of Thessaloniki "G. Papanikolaou" | Thessaloniki | Greece | Unknown status |
| General Hospital of Thessaloniki G. Gennimatas | Thessaloniki | Greece | Unknown status |
| "Thermi" Private Hosital | Thessaloniki | Greece | Unknown status |
| Opća bolnica Karlovac | Karlovac | Croatia | Unknown status |
| Specijalna bolnica Krapinske Toplice - Endokrinologija | Krapinske Toplice | Croatia | Unknown status |
| Poliklinika SLAVONIJA OSIJEK | Osijek | Croatia | Unknown status |
| Opca bolnica Pula | Pula | Croatia | Unknown status |
| Specijalna Bolnica Medico | Rijeka | Croatia | Unknown status |
| ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft. | Budapest | Hungary | Unknown status |
| Belinus Bt. | Debrecen | Hungary | Unknown status |
| Navneeth Memorial Hospital | Ahmedabad | India | Unknown status |
| Swasthya Diabetes Care | Ahmedabad | India | Unknown status |
| Jawahar Lal Nehru Govt. Medical College | Ajmer | India | Unknown status |
| Aligarh Muslim University | Aligarh | India | Unknown status |
| Ramaiah Memorial Hospital | Bangalore | India | Unknown status |
| Lifecare Hospital and Research Centre | Bangalore | India | Unknown status |
| Sparsh Hospital, Bhubaneshwar | Bhubaneswar | India | Unknown status |
| M.V.Hospital for Diabetes Pvt. Ltd. | Chennai | India | Unknown status |
| Maulana Azad Medical College | Delhi | India | Unknown status |
| Goa Medical College | Goa | India | Unknown status |
| Endolife Specialty Hospitals | Guntur | India | Unknown status |
| Gandhi Hospital & Medical college | Hyderabad | India | Unknown status |
| Osmania General Hospital | Hyderabad | India | Unknown status |
| Yashoda Hospital | Hyderabad | India | Unknown status |
| TOTALL Diabetes Hormone Institute | Indore | India | Unknown status |
| Diabetes, Thyroid and Endocrine Centre | Jaipur | India | Unknown status |
| Excel Endocrine Centre | Kolhāpur | India | Unknown status |
| BP Poddar Hospital | Kolkata | India | Unknown status |
| Medanta Lucknow Hospital | Lucknow | India | Unknown status |
| Dayanand Medical College & Hospital_Ludhiana | Ludhiana | India | Unknown status |
| All India Institute of Medical Sciences (AIIMS), Nagpur | Maharashtra | India | Unknown status |
| Seth GS Medical College & KEM Hospital | Mumbai | India | Unknown status |
| BSES MG hospital | Mumbai | India | Unknown status |
| K R Hospital | Mysuru | India | Unknown status |
| JIPMER | Puducherry | India | Unknown status |
| Lifepoint Multispecialty Hospital | Pune | India | Unknown status |
| Ashirwad Hospital and Research Centre | Thane | India | Unknown status |
| Govt Medical College | Vadodara | India | Unknown status |
| Yalamanchi Hospitals and Research centres pvt ltd | Vijaywada | India | Unknown status |
| Mahatma Gandhi Memorial Hospital, Sherpura | Warangal | India | Unknown status |
| Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha | Wardha | India | Unknown status |
| Medical Care and Research S.A. de C.V. | Mérida | Mexico | Unknown status |
| Eme Red Hospitalaria | Mérida | Mexico | Unknown status |
| FAICIC S. de R.L. de C.V. | Veracruz | Mexico | Unknown status |
| Klinik Kesihatan Bintulu | Bintulu | Malaysia | Unknown status |
| Klinik Kesihatan Greentown Ipoh | Ipoh | Malaysia | Unknown status |
| Klinik Kesihatan Cheras Baru | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Melaka | Malacca | Malaysia | Unknown status |
| Klinik Kesihatan Kuang | Rawang | Malaysia | Unknown status |
| Hospital Miri | Sarawak | Malaysia | Unknown status |
| Hospital Seri Manjung | Seri Manjung | Malaysia | Unknown status |
| Hospital Sultan Haji Ahmad Shah | Temerloh,Pahang | Malaysia | Unknown status |
| NZOZ Vita-Diabetica Malgorzata Buraczyk | Bialystok | Poland | Unknown status |
| Centrum Medyczne INTERCOR Sp. z o.o. | Bydgoszcz | Poland | Unknown status |
| Diab Serwis Popenda Spółka Jawna | Chorzów | Poland | Unknown status |
| NZOZ Euromedica | Grudziądz | Poland | Unknown status |
| Centra Medyczne Medyceusz Sp. z o.o. | Lodz | Poland | Unknown status |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. | Olsztyn | Poland | Unknown status |
| ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna | Opole | Poland | Unknown status |
| Trialmed CRS | Piotrkow Trybunalski | Poland | Unknown status |
| NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy | Poznań | Poland | Unknown status |
| ETG Siedlce | Siedlce | Poland | Unknown status |
| Clinmedica Research sp. z o.o. | Skierniewice | Poland | Unknown status |
| Centrum Medyczne Oporow | Wroclaw | Poland | Unknown status |
| Clinica Grivitei 224 S.R.L. | Brăila | Romania | Unknown status |
| Diabet Med SRL | Bucharest | Romania | Unknown status |
| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila | Bucharest | Romania | Unknown status |
| SC Nutrilife SRL | Bucharest | Romania | Unknown status |
| S.C. Dianutrilife Medica S.R.L. | Ploieşti | Romania | Unknown status |
| Clinica Korall S.R.L. Satu Mare | Satu Mare | Romania | Unknown status |
| Sc Mediab Srl | Târgu Mureş | Romania | Unknown status |
| Healthcare centre Zvezdara | Belgrade | Serbia | Unknown status |
| Healthcare centre Kragujevac | Kragujevac | Serbia | Unknown status |
| Healthcare centre Nis | Niš | Serbia | Unknown status |
| Ramathibodi Hospital | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital | Bangkok | Thailand | Unknown status |
| Siriraj Hospital | Bangkok Noi | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand | Unknown status |
| Srinagarind Hospital | Khon Kaen | Thailand | Unknown status |
| Thammasat University Hospital | Klong Luang | Thailand | Unknown status |
| Songklanagarind Hospital | Songkhla | Thailand | Unknown status |
| Hillcrest Family Health Center | Waco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.