Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes
NCT ID: NCT06083675
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2024-01-26
2027-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Semaglutide 25 mg
Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.
Semaglutide
Administered as oral tablets.
Semaglutide 50 mg
Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.
Semaglutide
Administered as oral tablets.
Empagliflozin 25 mg
Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.
Empagliflozin
Administered as oral tablets.
Metformin 2000 mg
Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.
Metformin
Administered as oral tablets.
Interventions
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Semaglutide
Administered as oral tablets.
Empagliflozin
Administered as oral tablets.
Metformin
Administered as oral tablets.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Treatment with any medication for the indication of weight management 90 days prior to screening.
* 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.
* 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.
* C-peptide \<1.5 nanograms per milliliter (ng/mL) at screening.
* 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).
* Impaired liver function, defined as Alanine aminotransferase (ALT) ≥2.5 times or Bilirubin \>1.5 times upper normal limit at screening.
* 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.
* Any contraindications for empagliflozin or metformin according to local labelling at the investigator's discretion
18 Years
60 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Hillcrest Family Health Center
Waco, Texas, United States
Instituto de Ciências Farmacêuticas
Goiânia, Goiás, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, Brazil
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
Kyustendil, , Bulgaria
Diagnostic-Consultative Centre "Sveti Georgi" Eood
Plovdiv, , Bulgaria
"Aipsomcemd - Dr. Petya Georgieva" Eood
Plovdiv, , Bulgaria
''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood
Samokov, , Bulgaria
"Medical center Medishtit Velisia" OOD
Stara Zagora, , Bulgaria
Diagnostic Consulting Center 1 Velingrad EOOD
Velingrad, , Bulgaria
MHAT- Hristo Botev AD
Vratsa, , Bulgaria
Poliklinika SLAVONIJA OSIJEK
Osijek, County of Osijek-Baranja, Croatia
Opca bolnica Karlovac
Karlovac, , Croatia
Specijalna bolnica Krapinske Toplice - Endokrinologija
Krapinske Toplice, , Croatia
Opca bolnica Pula
Pula, , Croatia
Specijalna bolnica Medico
Rijeka, , Croatia
Iatriko Psychicou Private Clinic
Athens, , Greece
"Laiko" General Hospital of Athens
Athens, , Greece
Iatriko Athinon (Athens Medical Canter)
Athens, , Greece
Iatriko Athinon 'Palaiou Falirou'
Athens, , Greece
University Hospital of Athens ATTIKON
Haidari-Athens, , Greece
University General Hospital of Ioannina,Internal Medicine
Ioannina, , Greece
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, , Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, , Greece
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, , Hungary
Belinus Bt.
Debrecen, , Hungary
Osmania General Hospital
Hyderabad, A.P., India
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Yalamanchi Hospitals and Research centres pvt ltd
Vijaywada, Andhra Pradesh, India
Navneeth Memorial Hospital
Ahmedabad, Gujarat, India
Govt Medical College
Vadodara, Gujarat, India
Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Lifecare Hospital and Research Centre
Bangalore, Karnataka, India
K R Hospital
Mysuru, Karnataka, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Goa Medical College
Goa, Maharashtra, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India
BSES MG hospital
Mumbai, Maharashtra, India
Ashirwad Hospital and Research Centre
Thāne, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
Wardha, Maharashtra, India
Maulana Azad Medical College
Delhi, New Delhi, India
Dayanand Medical College & Hospital_Ludhiana
Ludhiana, Punjab, India
Jawahar Lal Nehru Govt. Medical College
Ajmer, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
M.V.Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, India
Gandhi Hospital & Medical college
Hyderabad, Telangana, India
Yashoda hospital
Hyderabad, Telangana, India
Medanta Lucknow Hospital
Lucknow, Uttar Pradesh, India
BP Poddar Hospital
Kolkata, West Bengal, India
Swasthya Diabetes Care
Ahmedabad, , India
Aligarh Muslim University
Aligarh, , India
Sparsh Hospital, Bhubaneshwar
Bhubaneshwar, , India
All India Institute of Medical Sciences (AIIMS), Nagpur
Maharashtra, , India
JIPMER
Puducherry, , India
Lifepoint Multispecialty Hospital
Pune, , India
Mahatma Gandhi Memorial Hospital, Sherpura
Warangal, , India
Hospital Miri
Sarawak, Miri, Malaysia
Klinik Kesihatan Kuang
Rawang, Selangor, Malaysia
Klinik Kesihatan Bintulu
Bintulu, , Malaysia
Klinik Kesihatan Greentown Ipoh
Ipoh, , Malaysia
Klinik Kesihatan Cheras Baru
Kuala Lumpur, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Hospital Seri Manjung
Seri Manjung, , Malaysia
Hospital Sultan Haji Ahmad Shah
Temerloh,Pahang, , Malaysia
Eme Red Hospitalaria
Mérida, Yucatán, Mexico
Medical Care and Research S. A de C.V
Mérida, Yucatán, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
ETG Siedlce
Siedlce, Masovian Voivodeship, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, , Poland
Diab Serwis Popenda Spółka Jawna
Chorzów, , Poland
NZOZ Euromedica
Grudziądz, , Poland
Centra Medyczne Medyceusz Sp. z o.o.
Lodz, , Poland
Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
Olsztyn, , Poland
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna
Opole, , Poland
NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Poznan, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Trialmed CRS
Piotrkow Trybunalski, Łódź Voivodeship, Poland
Clinmedica Research sp. z o.o.
Skierniewice, Łódź Voivodeship, Poland
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, Romania
Sc Mediab Srl
Târgu Mureş, Mureș County, Romania
Clinica Grivitei 224 S.R.L.
Brăila, , Romania
SC Nutrilife SRL
Bucharest, , Romania
Diabet Med SRL
Bucharest, , Romania
S.C. Dianutrilife Medica S.R.L.
Ploieşti, , Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, , Romania
Healthcare centre Zvezdara
Belgrade, RS, Serbia
Healthcare centre Kragujevac
Kragujevac, RS, Serbia
Healthcare centre Nis
Niš, RS, Serbia
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Thammasat University Hospital
Klong Luang, Changwat Pathum Thani, Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Countries
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Other Identifiers
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U1111-1291-4976
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-7663
Identifier Type: -
Identifier Source: org_study_id
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