Diabetes Mellitus, Type 2Phase 3NCT06083675
Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes
A Phase 3 study testing Semaglutide, Empagliflozin and Metformin in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 100 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide, Empagliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 100 sitesin 13 countries
- Study dates
- 26 Jan 2024to 28 May 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
100 sites in 13 countries.
100 sites in 13 countries
India31 sites
Navneeth Memorial Hospital
Ahmedabad, Gujarat, 380009
Swasthya Diabetes Care
Ahmedabad, 390013
Jawahar Lal Nehru Govt. Medical College
Ajmer, Rajasthan, 305001
Aligarh Muslim University
Aligarh, 202002
Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Lifecare Hospital and Research Centre
Bangalore, Karnataka, 560092
Sparsh Hospital, Bhubaneshwar
Bhubaneswar, 751007
M.V.Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, 600 013
Maulana Azad Medical College
Delhi, New Delhi, 110002
Goa Medical College
Goa, Maharashtra, 403 202
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001
Osmania General Hospital
Hyderabad, A.P., 500 063
Gandhi Hospital & Medical college
Hyderabad, Telangana, 500003
Yashoda hospital
Hyderabad, Telangana, 500082
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008
BP Poddar Hospital
Kolkata, West Bengal, 700053
Medanta Lucknow Hospital
Lucknow, Uttar Pradesh, 226030
Dayanand Medical College & Hospital_Ludhiana
Ludhiana, Punjab, 141001
All India Institute of Medical Sciences (AIIMS), Nagpur
Maharashtra, 441108
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, 400012
BSES MG hospital
Mumbai, Maharashtra, 400058
K R Hospital
Mysuru, Karnataka, 570001
JIPMER
Puducherry, 605006
Lifepoint Multispecialty Hospital
Pune, 411057
Ashirwad Hospital and Research Centre
Thane, Maharashtra, 421004
Govt Medical College
Vadodara, Gujarat, 390001
Yalamanchi Hospitals and Research centres pvt ltd
Vijaywada, Andhra Pradesh, 520002
Mahatma Gandhi Memorial Hospital, Sherpura
Warangal, 506002
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
Wardha, Maharashtra, 442001
Poland12 sites
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, 15-879
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605
Diab Serwis Popenda Spółka Jawna
Chorzów, 41-500
NZOZ Euromedica
Grudziądz, 86-300
Centra Medyczne Medyceusz Sp. z o.o.
Lodz, 91-053
Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
Olsztyn, 10-117
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna
Opole, 45-301
Trialmed CRS
Piotrkow Trybunalski, Łódź Voivodeship, 97-300
NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Poznan, 61-853
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110
Clinmedica Research sp. z o.o.
Skierniewice, Łódź Voivodeship, 96-100
Centrum Medyczne Oporow
Wroclaw, 52-416
Greece10 sites
Iatriko Psychicou Private Clinic
Athens, 115 25
"Laiko" General Hospital of Athens
Athens, GR-11527
Iatriko Athinon (Athens Medical Canter)
Athens, GR-15125
Iatriko Athinon 'Palaiou Falirou'
Athens, GR-17562
University Hospital of Athens ATTIKON
Haidari-Athens, GR-12462
University General Hospital of Ioannina,Internal Medicine
Ioannina, 45500
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, GR-54635
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, GR-54643
"Thermi" Private Hosital
Thessaloniki, GR-57001
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, GR-57010
Malaysia8 sites
Klinik Kesihatan Bintulu
Bintulu, 97000
Klinik Kesihatan Greentown Ipoh
Ipoh, 30450
Klinik Kesihatan Cheras Baru
Kuala Lumpur, 56100
Hospital Melaka
Malacca, 75400
Klinik Kesihatan Kuang
Rawang, Selangor, 48050
Hospital Miri
Sarawak, Miri, 98000
Hospital Seri Manjung
Seri Manjung, 32040
Hospital Sultan Haji Ahmad Shah
Temerloh,Pahang, 28000
Bulgaria7 sites
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
Kyustendil, 2500
Diagnostic-Consultative Centre "Sveti Georgi" Eood
Plovdiv, 4002
"Aipsomcemd - Dr. Petya Georgieva" Eood
Plovdiv, 4018
''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood
Samokov, 1000
"Medical center Medishtit Velisia" OOD
Stara Zagora, 6000
Diagnostic Consulting Center 1 Velingrad EOOD
Velingrad, 4600
MHAT- Hristo Botev AD
Vratsa, 3000
Romania7 sites
Clinica Grivitei 224 S.R.L.
Brăila, 810197
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, 020475
SC Nutrilife SRL
Bucharest, 013764
Diabet Med SRL
Bucharest, 050913
S.C. Dianutrilife Medica S.R.L.
Ploieşti, 100561
Clinica Korall S.R.L. Satu Mare
Satu Mare, 440055
Sc Mediab Srl
Târgu Mureş, Mureș County, 540142
Thailand7 sites
Rajavithi Hospital
Bangkok, 10400
Ramathibodi Hospital
Bangkok, 10400
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Srinagarind Hospital
Khon Kaen, 40002
Thammasat University Hospital
Klong Luang, Changwat Pathum Thani, 12120
Songklanagarind Hospital
Songkhla, 90110
Croatia5 sites
Opca bolnica Karlovac
Karlovac, 47000
Specijalna bolnica Krapinske Toplice - Endokrinologija
Krapinske Toplice, 49217
Poliklinika SLAVONIJA OSIJEK
Osijek, County of Osijek-Baranja, 31000
Opca bolnica Pula
Pula, 52100
Specijalna bolnica Medico
Rijeka, 51000
Brazil4 sites
Instituto de Ciências Farmacêuticas
Goiânia, Goiás, 74935-330
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, 90430-001
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200
Mexico3 sites
Eme Red Hospitalaria
Mérida, Yucatán, 97070
Medical Care and Research S. A de C.V
Mérida, Yucatán, 97070
FAICIC S. de R.L. de C.V.
Veracruz, 91900
Serbia3 sites
Healthcare centre Zvezdara
Belgrade, RS, 11050
Healthcare centre Kragujevac
Kragujevac, RS, 34000
Healthcare centre Nis
Niš, RS, 18000
Hungary2 sites
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1089
Belinus Bt.
Debrecen, 4025
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide, Empagliflozin, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Administered as oral tablets.
EmpagliflozinDrug
Administered as oral tablets.
MetforminDrug
Administered as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 25 mg | Experimental | Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period. Receives: Drug: Semaglutide |
| Semaglutide 50 mg | Experimental | Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period. Receives: Drug: Semaglutide |
| Empagliflozin 25 mg | Experimental | Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period. Receives: Drug: Empagliflozin |
| Metformin 2000 mg | Experimental | Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Measured in Percentage (%)-points.
Measured: From randomisation (week 0) to week 52
Secondary outcomes (44)
Change in body weight
Measured in kilograms (kg).
Measured: From randomisation (week 0) to week 52
Change in fasting plasma glucose (FPG)
Measured in millimoles per liter (mmol/L).
Measured: From randomisation (week 0) to week 52
Change in 7 point self measured plasma glucose (SMPG) mean profile
Measured in mmol/L.
Measured: From randomisation (week 0) to week 52
Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments
Measured in mmol/L.
Measured: From randomisation (week 0) to week 52
Relative change in body weight
Measured in Percentage (%).
Measured: From randomisation (week 0) to week 52
Change in waist circumference
Measured in centimeters (cm).
Measured: From randomisation (week 0) to week 52
HbA1c less than or equal to (≤) 6.5% (Yes/No)
Measured as count of participants.
Measured: At week 52
HbA1c less than (<) 7% (Yes/No)
Measured as count of participants.
Measured: At week 52
Body weight reduction greater than equal to ( ≥) 5% (Yes/No)
Measured as count of participants.
Measured: At week 52
Body weight reduction ≥10% (Yes/No)
Measured as count of participants.
Measured: At week 52
Body weight reduction ≥15% (Yes/No)
Measured as count of participants.
Measured: At week 52
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
Measured as count of participants.
Measured: At week 52
Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Measured: From randomisation (week 0) to week 52
Change in diastolic blood pressure
Measured in mmHg.
Measured: From randomisation (week 0) to week 52
Change in High-sensitivity C-reactive protein (hsCRP)
Measured in milligrams per liter (mg/L).
Measured: From randomisation (week 0) to week 52
Time to rescue medication
Measured in days.
Measured: From randomisation (week 0) to week 104
Change in HbA1c
Measured in %-points.
Measured: From randomisation (week 0) to week 104
Change in body weight
Measured in kg.
Measured: From randomisation (week 0) to week 104
Change in FPG
Measured in mmol/L.
Measured: From randomisation (week 0) to week 104
Change in 7 point SMPG mean profile
Measured in mmol/L.
Measured: From randomisation (week 0) to week 104
Change in 7-point SMPG mean post prandial increments
Measured in mmol/L
Measured: From randomisation (week 0) to week 104
Relative change in body weight
Measured in Percentage.
Measured: From randomisation (week 0) to week 104
Change in waist circumference
Measured in cm.
Measured: From randomisation (week 0) to week 104
HbA1c ≤6.5% (Yes/No)
Measured as count of participants.
Measured: At week 104
HbA1c <7.0% (Yes/No)
Measured as count of participants.
Measured: At week 104
Body weight reduction ≥5% (Yes/No)
Measured as count of participants.
Measured: At week 104
Body weight reduction ≥10% (Yes/No)
Measured as count of participants.
Measured: At week 104
Body weight reduction ≥15% (Yes/No)
Measured as count of participants.
Measured: At week 104
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
Measured as count of participants.
Measured: At week 104
Change in systolic blood pressure
Measured in mmHg.
Measured: From randomisation (week 0) to week 104
Change in diastolic blood pressure
Measured in mmHg.
Measured: From randomisation (week 0) to week 104
Change in hsCRP
Measured in mg/L.
Measured: From randomisation (week 0) to week 104
Treatment emergent adverse events
Measured as count of events.
Measured: From randomisation (week 0) to week 52
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
Measured as count of episodes.
Measured: From randomisation (week 0) to week 52
Treatment emergent adverse events
Measured as count of events.
Measured: From randomisation (week 0) to follow-up visit (week 109)
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
Measured as count of episodes.
Measured: From randomisation (week 0) to follow-up visit (week 109)
Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain
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.
Measured: From randomisation (week 0) to week 52
Change in CoEQ score - Craving for Savory domain
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.
Measured: From randomisation (week 0) to week 52
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain
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).
Measured: From randomisation (week 0) to week 52
Change in American Heart Association (AHA) Life's Simple 7 summary score
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.
Measured: From randomisation (week 0) to week 52
Change in CoEQ score - Craving Control domain
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.
Measured: From randomisation (week 0) to week 104
Change in CoEQ score - Craving for Savory domain
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.
Measured: From randomisation (week 0) to week 104
Change in IWQOL-Lite-CT score - Physical function domain
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).
Measured: From randomisation (week 0) to week 104
Change in AHA Life's Simple 7 summary score
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.
Measured: From randomisation (week 0) to week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start26 Jan 2024 (estimated)
- Primary completion24 Jan 2025 (estimated)
- Study completion28 May 2027 (estimated)
Why it stopped: Due to internal reprioritization, trial was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083675
- Sponsor's protocol ID
- NN9924-7663
- Other IDs
- U1111-1291-4976
- Status last verified
- Feb 2024
- First submitted
- 9 Oct 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06083675
- Acronym / sponsor ID
- NN9924-7663
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to internal reprioritization, trial was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (estimated)
- Primary completion
- 24 Jan 2025 (estimated)
- Study completion
- 28 May 2027 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 25 mg | Experimental | Drug: SemaglutideParticipants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period. |
| Semaglutide 50 mg | Experimental | Drug: SemaglutideParticipants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period. |
| Empagliflozin 25 mg | Experimental | Drug: EmpagliflozinParticipants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period. |
| Metformin 2000 mg | Experimental | Drug: MetforminParticipants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAdministered as oral tablets. | Drug | Semaglutide 25 mg, Semaglutide 50 mg |
| EmpagliflozinAdministered as oral tablets. | Drug | Empagliflozin 25 mg |
| MetforminAdministered as oral tablets. | Drug | Metformin 2000 mg |
Primary outcome
Change in glycated haemoglobin (HbA1c)
Time frame: From randomisation (week 0) to week 52
Measured in Percentage (%)-points.
44 secondary outcomes
Change in body weight
Time frame: From randomisation (week 0) to week 52
Change in fasting plasma glucose (FPG)
Time frame: From randomisation (week 0) to week 52
Change in 7 point self measured plasma glucose (SMPG) mean profile
Time frame: From randomisation (week 0) to week 52
Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments
Time frame: From randomisation (week 0) to week 52
Relative change in body weight
Time frame: From randomisation (week 0) to week 52
Change in waist circumference
Time frame: From randomisation (week 0) to week 52
HbA1c less than or equal to (≤) 6.5% (Yes/No)
Time frame: At week 52
HbA1c less than (<) 7% (Yes/No)
Time frame: At week 52
Body weight reduction greater than equal to ( ≥) 5% (Yes/No)
Time frame: At week 52
Body weight reduction ≥10% (Yes/No)
Time frame: At week 52
Body weight reduction ≥15% (Yes/No)
Time frame: At week 52
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
Time frame: At week 52
Change in systolic blood pressure
Time frame: From randomisation (week 0) to week 52
Change in diastolic blood pressure
Time frame: From randomisation (week 0) to week 52
Change in High-sensitivity C-reactive protein (hsCRP)
Time frame: From randomisation (week 0) to week 52
Time to rescue medication
Time frame: From randomisation (week 0) to week 104
Change in HbA1c
Time frame: From randomisation (week 0) to week 104
Change in body weight
Time frame: From randomisation (week 0) to week 104
Change in FPG
Time frame: From randomisation (week 0) to week 104
Change in 7 point SMPG mean profile
Time frame: From randomisation (week 0) to week 104
Change in 7-point SMPG mean post prandial increments
Time frame: From randomisation (week 0) to week 104
Relative change in body weight
Time frame: From randomisation (week 0) to week 104
Change in waist circumference
Time frame: From randomisation (week 0) to week 104
HbA1c ≤6.5% (Yes/No)
Time frame: At week 104
HbA1c <7.0% (Yes/No)
Time frame: At week 104
Body weight reduction ≥5% (Yes/No)
Time frame: At week 104
Body weight reduction ≥10% (Yes/No)
Time frame: At week 104
Body weight reduction ≥15% (Yes/No)
Time frame: At week 104
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
Time frame: At week 104
Change in systolic blood pressure
Time frame: From randomisation (week 0) to week 104
Change in diastolic blood pressure
Time frame: From randomisation (week 0) to week 104
Change in hsCRP
Time frame: From randomisation (week 0) to week 104
Treatment emergent adverse events
Time frame: From randomisation (week 0) to week 52
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
Time frame: From randomisation (week 0) to week 52
Treatment emergent adverse events
Time frame: From randomisation (week 0) to follow-up visit (week 109)
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
Time frame: From randomisation (week 0) to follow-up visit (week 109)
Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain
Time frame: From randomisation (week 0) to week 52
Change in CoEQ score - Craving for Savory domain
Time frame: From randomisation (week 0) to week 52
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain
Time frame: From randomisation (week 0) to week 52
Change in American Heart Association (AHA) Life's Simple 7 summary score
Time frame: From randomisation (week 0) to week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
100 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide, Empagliflozin and Metformin in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 100 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in India, Poland, Greece, Malaysia, Bulgaria and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (time frame: From randomisation (week 0) to week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.