Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06083675
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide 25 mg Semaglutide Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period. Semaglutide 50 mg Semaglutide Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period. Metformin 2000 mg Metformin Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period. Empagliflozin 25 mg Empagliflozin Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.
- Primary Outcome Measures
Name Time Method Change in glycated haemoglobin (HbA1c) From randomisation (week 0) to week 52 Measured in Percentage (%)-points.
- Secondary Outcome Measures
Name Time Method Change in FPG From randomisation (week 0) to week 104 Measured in mmol/L.
Change in 7 point SMPG mean profile From randomisation (week 0) to week 104 Measured in mmol/L.
Change in 7-point SMPG mean post prandial increments From randomisation (week 0) to week 104 Measured in mmol/L
Relative change in body weight From randomisation (week 0) to week 104 Measured in Percentage.
HbA1c less than or equal to (≤) 6.5% (Yes/No) At week 52 Measured as count of participants.
HbA1c less than (<) 7% (Yes/No) At week 52 Measured as count of participants.
Change in body weight From randomisation (week 0) to week 104 Measured in kg.
Change in 7 point self measured plasma glucose (SMPG) mean profile From randomisation (week 0) to week 52 Measured in mmol/L.
Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments From randomisation (week 0) to week 52 Measured in mmol/L.
Change in diastolic blood pressure From randomisation (week 0) to week 104 Measured in mmHg.
HbA1c ≤6.5% (Yes/No) At week 104 Measured as count of participants.
Change in waist circumference From randomisation (week 0) to week 104 Measured in cm.
HbA1c <7.0% and body weight reduction ≥5% (Yes/No) At week 104 Measured as count of participants.
Body weight reduction greater than equal to ( ≥) 5% (Yes/No) At week 52 Measured as count of participants.
Change in fasting plasma glucose (FPG) From randomisation (week 0) to week 52 Measured in millimoles per liter (mmol/L).
Body weight reduction ≥10% (Yes/No) At week 104 Measured as count of participants.
Body weight reduction ≥15% (Yes/No) At week 104 Measured as count of participants.
Change in systolic blood pressure From randomisation (week 0) to week 104 Measured in mmHg.
Change in High-sensitivity C-reactive protein (hsCRP) From randomisation (week 0) to week 52 Measured in milligrams per liter (mg/L).
Time to rescue medication From randomisation (week 0) to week 104 Measured in days.
Change in HbA1c From randomisation (week 0) to week 104 Measured in %-points.
HbA1c <7.0% (Yes/No) At week 104 Measured as count of participants.
Body weight reduction ≥5% (Yes/No) At week 104 Measured as count of participants.
Change in hsCRP From randomisation (week 0) to week 104 Measured in mg/L.
Treatment emergent adverse events From randomisation (week 0) to follow-up visit (week 109) Measured as count of events.
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes From randomisation (week 0) to follow-up visit (week 109) Measured as count of episodes.
Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain From randomisation (week 0) to week 52 CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
Change in CoEQ score - Craving for Savory domain From randomisation (week 0) to week 104 CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving.
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain From randomisation (week 0) to week 52 IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100).
Change in American Heart Association (AHA) Life's Simple 7 summary score From randomisation (week 0) to week 52 The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health.
Change in CoEQ score - Craving Control domain From randomisation (week 0) to week 104 CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
Change in IWQOL-Lite-CT score - Physical function domain From randomisation (week 0) to week 104 IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100).
Change in AHA Life's Simple 7 summary score From randomisation (week 0) to week 104 The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health.
Trial Locations
- Locations (100)
Songklanagarind Hospital
🇹🇭Songkla, Thailand
General Hospital of Thessaloniki "G.Papanikolaou"
🇬🇷Thessaloniki, Greece
ETG Siedlce
🇵🇱Siedlce, Masovian, Poland
Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
🇵🇱Olsztyn, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Centrum Medyczne Intercor Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Clinica Grivitei 224 S.R.L.
🇷🇴Braila, Romania
MHAT- Hristo Botev AD
🇧🇬Vratsa, Bulgaria
CPCLIN - Centro de Pesquisas Clínicas
🇧🇷São Paulo, Sao Paulo, Brazil
Diagnostic-Consultative Centre "Sveti Georgi" Eood
🇧🇬Plovdiv, Bulgaria
Sparsh Hospital, Bhubaneshwar
🇮🇳Bhubaneshwar, India
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
Klinik Kesihatan Cheras Baru
🇲🇾Kuala Lumpur, Malaysia
Medical Care and Research S. A de C.V
🇲🇽Merida, Yucatan, Mexico
Dayanand Medical College & Hospital_Ludhiana
🇮🇳Ludhiana, Punjab, India
''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood
🇧🇬Samokov, Bulgaria
Lifecare Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
Opca bolnica Karlovac
🇭🇷Karlovac, Croatia
Swasthya Diabetes Care
🇮🇳Ahmedabad, India
Ashirwad Hospital and Research Centre
🇮🇳Thane, Maharashtra, India
Medanta Lucknow Hospital
🇮🇳Lucknow, Uttar Pradesh, India
"Medical center Medishtit Velisia" OOD
🇧🇬Stara Zagora, Bulgaria
Ramaiah Memorial Hospital
🇮🇳Bangalore, Karnataka, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
Seth GS Medical College & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
🇮🇳Wardha, Maharashtra, India
Iatriko Psychicou Private Clinic
🇬🇷Athens, Greece
Govt Medical College
🇮🇳Vadodara, Gujrat, India
Goa Medical College
🇮🇳Goa, Maharashtra, India
K R Hospital
🇮🇳Mysuru, Karnataka, India
Excel Endocrine Centre
🇮🇳Kolhapur, Maharashtra, India
Gandhi Hospital & Medical college
🇮🇳Hyderabad, Telengana, India
Yashoda hospital
🇮🇳Hyderabad, Telengana, India
M.V.Hospital for Diabetes Pvt. Ltd.
🇮🇳Chennai, Tamil Nadu, India
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Jawahar Lal Nehru Govt. Medical College
🇮🇳Ajmer, Rajasthan, India
Siriraj Hospital
🇹🇭Bangkok Noi, Bangkok, Thailand
Instituto de Ciências Farmacêuticas
🇧🇷Goiânia, Goias, Brazil
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
🇧🇬Kyustendil, Bulgaria
"Aipsomcemd - Dr. Petya Georgieva" Eood
🇧🇬Plovdiv, Bulgaria
Poliklinika SLAVONIJA OSIJEK
🇭🇷Osijek, Osječko - Baranjska Županija, Croatia
Diagnostic Consulting Center 1 Velingrad EOOD
🇧🇬Velingrad, Bulgaria
Iatriko Athinon (Athens Medical Canter)
🇬🇷Athens, Greece
Iatriko Athinon 'Palaiou Falirou'
🇬🇷Athens, Greece
Opca bolnica Pula
🇭🇷Pula, Croatia
Specijalna bolnica Medico
🇭🇷Rijeka, Croatia
University Hospital of Athens ATTIKON
🇬🇷Haidari-Athens, Greece
University General Hospital of Ioannina,Internal Medicine
🇬🇷Ioannina, Greece
"Laiko" General Hospital of Athens
🇬🇷Athens, Greece
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki 'G. Gennimatas
🇬🇷Thessaloniki, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
🇬🇷Thessaloniki, Greece
Belinus Bt.
🇭🇺Debrecen, Hungary
Endolife Specialty Hospitals
🇮🇳Guntur, Andhra Pradesh, India
Yalamanchi Hospitals and Research centres pvt ltd
🇮🇳Vijaywada, Andhra Pradesh, India
Maulana Azad Medical College
🇮🇳Delhi, New Delhi, India
BP Poddar Hospital
🇮🇳Kolkata,, West Bengal, India
Klinik Kesihatan Kuang
🇲🇾Rawang, Selangor, Malaysia
Klinik Kesihatan Greentown Ipoh
🇲🇾Ipoh, Malaysia
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
Clinmedica Research sp. z o.o.
🇵🇱Skierniewice, Lodzkie, Poland
Eme Red Hospitalaria
🇲🇽Mérida, Yucatán, Mexico
Diab Serwis Popenda Spółka Jawna
🇵🇱Chorzów, Poland
Sc Mediab Srl
🇷🇴Tirgu Mures, Mures, Romania
Trialmed CRS
🇵🇱Piotrków Trybunalski, Łódzkie, Poland
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna
🇵🇱Opole, Poland
NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy
🇵🇱Poznań, Poland
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
🇷🇴Bucharest, Bucurestii, Romania
SC Nutrilife SRL
🇷🇴Bucharest, Romania
S.C. Dianutrilife Medica S.R.L.
🇷🇴Ploiesti, Romania
Diabet Med SRL
🇷🇴Bucuresti, Romania
Healthcare centre Zvezdara
🇷🇸Belgrade, RS, Serbia
Rajavithi Hospital
🇹🇭Bangkok, Thailand
Thammasat University Hospital
🇹🇭Klong Luang, Pathum Thani, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
CPQuali Pesquisa Clínica Ltda
🇧🇷São Paulo, Sao Paulo, Brazil
Specijalna bolnica Krapinske Toplice - Endokrinologija
🇭🇷Krapinske Toplice, Croatia
Navneeth Memorial Hospital
🇮🇳Ahmedabad, Gujrat, India
All India Institute of Medical Sciences (AIIMS), Nagpur
🇮🇳Maharashtra, India
Clinica Korall S.R.L. Satu Mare
🇷🇴Satu-Mare, Romania
BSES MG hospital
🇮🇳Mumbai, Maharashtra, India
Mahatma Gandhi Memorial Hospital, Sherpura
🇮🇳Warangal, India
Hospital Miri
🇲🇾Sarawak, Miri, Malaysia
Hospital Sultan Haji Ahmad Shah
🇲🇾Temerloh,Pahang, Malaysia
NZOZ Vita-Diabetica Malgorzata Buraczyk
🇵🇱Bialystok, Podlaskie Voivodeship, Poland
Healthcare centre Kragujevac
🇷🇸Kragujevac, RS, Serbia
Osmania General Hospital
🇮🇳Hyderabad, A.p., India
Lifepoint Multispecialty Hospital
🇮🇳Pune, India
Hospital Melaka
🇲🇾Melaka, Malaysia
Hospital Seri Manjung
🇲🇾Seri Manjung, Malaysia
Healthcare centre Nis
🇷🇸Nis, RS, Serbia
Aligarh Muslim University
🇮🇳Aligarh, India
Klinik Kesihatan Bintulu
🇲🇾Bintulu, Malaysia
JIPMER
🇮🇳Puducherry, India
NZOZ Euromedica
🇵🇱Grudziadz, Poland
Centra Medyczne Medyceusz Sp. z o.o.
🇵🇱Łódź, Poland
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
🇭🇺Budapest, Hungary