Clinical trial NCT06083675: Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From randomisation (week 0) to week 52
Secondary outcomes:
measure: Change in body weight
timeFrame: From randomisation (week 0) to week 52
measure: Change in fasting plasma glucose (FPG)
timeFrame: From randomisation (week 0) to week 52
measure: Change in 7 point self measured plasma glucose (SMPG) mean profile
timeFrame: From randomisation (week 0) to week 52
measure: Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments
timeFrame: From randomisation (week 0) to week 52
measure: Relative change in body weight
timeFrame: From randomisation (week 0) to week 52
measure: Change in waist circumference
timeFrame: From randomisation (week 0) to week 52
measure: HbA1c less than or equal to (≤) 6.5% (Yes/No)
timeFrame: At week 52
measure: HbA1c less than (<) 7% (Yes/No)
timeFrame: At week 52
measure: Body weight reduction greater than equal to ( ≥) 5% (Yes/No)
timeFrame: At week 52
measure: Body weight reduction ≥10% (Yes/No)
timeFrame: At week 52
measure: Body weight reduction ≥15% (Yes/No)
timeFrame: At week 52
measure: HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
timeFrame: At week 52
measure: Change in systolic blood pressure
timeFrame: From randomisation (week 0) to week 52
measure: Change in diastolic blood pressure
timeFrame: From randomisation (week 0) to week 52
measure: Change in High-sensitivity C-reactive protein (hsCRP)
timeFrame: From randomisation (week 0) to week 52
measure: Time to rescue medication
timeFrame: From randomisation (week 0) to week 104
measure: Change in HbA1c
timeFrame: From randomisation (week 0) to week 104
measure: Change in body weight
timeFrame: From randomisation (week 0) to week 104
measure: Change in FPG
timeFrame: From randomisation (week 0) to week 104
measure: Change in 7 point SMPG mean profile
timeFrame: From randomisation (week 0) to week 104
measure: Change in 7-point SMPG mean post prandial increments
timeFrame: From randomisation (week 0) to week 104
measure: Relative change in body weight
timeFrame: From randomisation (week 0) to week 104
measure: Change in waist circumference
timeFrame: From randomisation (week 0) to week 104
measure: HbA1c ≤6.5% (Yes/No)
timeFrame: At week 104
measure: HbA1c <7.0% (Yes/No)
timeFrame: At week 104
measure: Body weight reduction ≥5% (Yes/No)
timeFrame: At week 104
measure: Body weight reduction ≥10% (Yes/No)
timeFrame: At week 104
measure: Body weight reduction ≥15% (Yes/No)
timeFrame: At week 104
measure: HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
timeFrame: At week 104
measure: Change in systolic blood pressure
timeFrame: From randomisation (week 0) to week 104
measure: Change in diastolic blood pressure
timeFrame: From randomisation (week 0) to week 104
measure: Change in hsCRP
timeFrame: From randomisation (week 0) to week 104
measure: Treatment emergent adverse events
timeFrame: From randomisation (week 0) to week 52
measure: Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
timeFrame: From randomisation (week 0) to week 52
measure: Treatment emergent adverse events
timeFrame: From randomisation (week 0) to follow-up visit (week 109)
measure: Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
timeFrame: From randomisation (week 0) to follow-up visit (week 109)
measure: Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain
timeFrame: From randomisation (week 0) to week 52
measure: Change in CoEQ score - Craving for Savory domain
timeFrame: From randomisation (week 0) to week 52
measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain
timeFrame: From randomisation (week 0) to week 52
measure: Change in American Heart Association (AHA) Life's Simple 7 summary score
timeFrame: From randomisation (week 0) to week 52
measure: Change in CoEQ score - Craving Control domain
timeFrame: From randomisation (week 0) to week 104
measure: Change in CoEQ score - Craving for Savory domain
timeFrame: From randomisation (week 0) to week 104
measure: Change in IWQOL-Lite-CT score - Physical function domain
timeFrame: From randomisation (week 0) to week 104
measure: Change in AHA Life's Simple 7 summary score
timeFrame: From randomisation (week 0) to week 104
Other outcomes:
Locations:
city: Waco
country: United States
facility: Hillcrest Family Health Center
state: Texas
city: Goiânia
country: Brazil
facility: Instituto de Ciências Farmacêuticas
state: Goias
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Ltda
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas
state: Sao Paulo
city: Kyustendil
country: Bulgaria
facility: Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
city: Plovdiv
country: Bulgaria
facility: Diagnostic-Consultative Centre "Sveti Georgi" Eood
city: Plovdiv
country: Bulgaria
facility: "Aipsomcemd - Dr. Petya Georgieva" Eood
city: Samokov
country: Bulgaria
facility: ''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood
city: Stara Zagora
country: Bulgaria
facility: "Medical center Medishtit Velisia" OOD
city: Velingrad
country: Bulgaria
facility: Diagnostic Consulting Center 1 Velingrad EOOD
city: Vratsa
country: Bulgaria
facility: MHAT- Hristo Botev AD
city: Osijek
country: Croatia
facility: Poliklinika SLAVONIJA OSIJEK
state: Osječko - Baranjska Županija
city: Karlovac
country: Croatia
facility: Opca bolnica Karlovac
city: Krapinske Toplice
country: Croatia
facility: Specijalna bolnica Krapinske Toplice - Endokrinologija
city: Pula
country: Croatia
facility: Opca bolnica Pula
city: Rijeka
country: Croatia
facility: Specijalna bolnica Medico
city: Athens
country: Greece
facility: Iatriko Psychicou Private Clinic
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Iatriko Athinon (Athens Medical Canter)
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Haidari-Athens
country: Greece
facility: University Hospital of Athens ATTIKON
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina,Internal Medicine
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G.Papanikolaou"
city: Budapest
country: Hungary
facility: ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Debrecen
country: Hungary
facility: Belinus Bt.
city: Hyderabad
country: India
facility: Osmania General Hospital
state: A.p.
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: Vijaywada
country: India
facility: Yalamanchi Hospitals and Research centres pvt ltd
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Navneeth Memorial Hospital
state: Gujrat
city: Vadodara
country: India
facility: Govt Medical College
state: Gujrat
city: Bangalore
country: India
facility: Ramaiah Memorial Hospital
state: Karnataka
city: Bangalore
country: India
facility: Lifecare Hospital and Research Centre
state: Karnataka
city: Mysuru
country: India
facility: K R Hospital
state: Karnataka
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Goa
country: India
facility: Goa Medical College
state: Maharashtra
city: Kolhapur
country: India
facility: Excel Endocrine Centre
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharashtra
city: Mumbai
country: India
facility: BSES MG hospital
state: Maharashtra
city: Thane
country: India
facility: Ashirwad Hospital and Research Centre
state: Maharashtra
city: Wardha
country: India
facility: Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
state: Maharashtra
city: Delhi
country: India
facility: Maulana Azad Medical College
state: New Delhi
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital_Ludhiana
state: Punjab
city: Ajmer
country: India
facility: Jawahar Lal Nehru Govt. Medical College
state: Rajasthan
city: Jaipur
country: India
facility: Diabetes, Thyroid and Endocrine Centre
state: Rajasthan
city: Chennai
country: India
facility: M.V.Hospital for Diabetes Pvt. Ltd.
state: Tamil Nadu
city: Hyderabad
country: India
facility: Gandhi Hospital & Medical college
state: Telengana
city: Hyderabad
country: India
facility: Yashoda hospital
state: Telengana
city: Lucknow
country: India
facility: Medanta Lucknow Hospital
state: Uttar Pradesh
city: Kolkata,
country: India
facility: BP Poddar Hospital
state: West Bengal
city: Ahmedabad
country: India
facility: Swasthya Diabetes Care
city: Aligarh
country: India
facility: Aligarh Muslim University
city: Bhubaneshwar
country: India
facility: Sparsh Hospital, Bhubaneshwar
city: Maharashtra
country: India
facility: All India Institute of Medical Sciences (AIIMS), Nagpur
city: Puducherry
country: India
facility: JIPMER
city: Pune
country: India
facility: Lifepoint Multispecialty Hospital
city: Warangal
country: India
facility: Mahatma Gandhi Memorial Hospital, Sherpura
city: Sarawak
country: Malaysia
facility: Hospital Miri
state: Miri
city: Rawang
country: Malaysia
facility: Klinik Kesihatan Kuang
state: Selangor
city: Bintulu
country: Malaysia
facility: Klinik Kesihatan Bintulu
city: Ipoh
country: Malaysia
facility: Klinik Kesihatan Greentown Ipoh
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kesihatan Cheras Baru
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Seri Manjung
country: Malaysia
facility: Hospital Seri Manjung
city: Temerloh,Pahang
country: Malaysia
facility: Hospital Sultan Haji Ahmad Shah
city: Merida
country: Mexico
facility: Medical Care and Research S. A de C.V
state: Yucatan
city: Mérida
country: Mexico
facility: Eme Red Hospitalaria
state: Yucatán
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Skierniewice
country: Poland
facility: Clinmedica Research sp. z o.o.
state: Lodzkie
city: Siedlce
country: Poland
facility: ETG Siedlce
state: Masovian
city: Bialystok
country: Poland
facility: NZOZ Vita-Diabetica Malgorzata Buraczyk
state: Podlaskie Voivodeship
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Intercor Sp. z o.o.
city: Chorzów
country: Poland
facility: Diab Serwis Popenda Spółka Jawna
city: Grudziadz
country: Poland
facility: NZOZ Euromedica
city: Olsztyn
country: Poland
facility: Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
city: Opole
country: Poland
facility: ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna
city: Poznań
country: Poland
facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Łódź
country: Poland
facility: Centra Medyczne Medyceusz Sp. z o.o.
city: Piotrków Trybunalski
country: Poland
facility: Trialmed CRS
state: Łódzkie
city: Bucharest
country: Romania
facility: Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
state: Bucurestii
city: Targu Mures
country: Romania
facility: Sc Mediab Srl
state: Mures
city: Tirgu Mures
country: Romania
facility: Sc Mediab Srl
state: Mures
city: Braila
country: Romania
facility: Clinica Grivitei 224 S.R.L.
city: Bucharest
country: Romania
facility: SC Nutrilife SRL
city: Bucuresti
country: Romania
facility: Diabet Med SRL
city: Ploiesti
country: Romania
facility: S.C. Dianutrilife Medica S.R.L.
city: Satu-Mare
country: Romania
facility: Clinica Korall S.R.L. Satu Mare
city: Belgrade
country: Serbia
facility: Healthcare centre Zvezdara
state: RS
city: Kragujevac
country: Serbia
facility: Healthcare centre Kragujevac
state: RS
city: Nis
country: Serbia
facility: Healthcare centre Nis
state: RS
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Klong Luang
country: Thailand
facility: Thammasat University Hospital
state: Pathum Thani
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Songkla
country: Thailand
facility: Songklanagarind Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: