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

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 Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide; Drug: Empagliflozin; Drug: Metformin

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Goias
    • Goiânia, Goias, Brazil, 74935-330
      • Instituto de Ciências Farmacêuticas
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
      • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01228-000
      • CPQuali Pesquisa Clinica Ltda
    • São Paulo, Sao Paulo, Brazil, 01228-200
      • CPCLIN - Centro de Pesquisas Clínicas
• Bulgaria
  • Kyustendil, Bulgaria, 2500
    • Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
  • Plovdiv, Bulgaria, 4002
    • Diagnostic-Consultative Centre "Sveti Georgi" Eood
  • Plovdiv, Bulgaria, 4018
    • "Aipsomcemd - Dr. Petya Georgieva" Eood
  • Samokov, Bulgaria, 1000
    • ''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood
  • Stara Zagora, Bulgaria, 6000
    • "Medical center Medishtit Velisia" OOD
  • Velingrad, Bulgaria, 4600
    • Diagnostic Consulting Center 1 Velingrad EOOD
  • Vratsa, Bulgaria, 3000
    • MHAT- Hristo Botev AD
• Croatia
  • Karlovac, Croatia, 47000
    • Opca Bolnica Karlovac
  • Krapinske Toplice, Croatia, 49217
    • Specijalna bolnica Krapinske Toplice - Endokrinologija
  • Pula, Croatia, 52100
    • Opca bolnica Pula
  • Rijeka, Croatia, 51000
    • Specijalna bolnica Medico
  • Osječko - Baranjska Županija
    • Osijek, Osječko - Baranjska Županija, Croatia, 31000
      • Poliklinika SLAVONIJA OSIJEK
• Greece
  • Athens, Greece, 115 25
    • Iatriko Psychicou Private Clinic
  • Athens, Greece, GR-11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, GR-15125
    • Iatriko Athinon (Athens Medical Canter)
  • Athens, Greece, GR-17562
    • Iatriko Athinon 'Palaiou Falirou'
  • Haidari-Athens, Greece, GR-12462
    • University Hospital of Athens ATTIKON
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina,Internal Medicine
  • Thessaloniki, Greece, GR-54635
    • General Hospital of Thessaloniki 'G. Gennimatas
  • Thessaloniki, Greece, GR-54643
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
  • Thessaloniki, Greece, GR-57001
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, GR-57010
    • General Hospital of Thessaloniki "G.Papanikolaou"
• Hungary
  • Budapest, Hungary, 1089
    • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Debrecen, Hungary, 4025
    • Belinus Bt.
• India
  • Ahmedabad, India, 390013
    • Swasthya Diabetes Care
  • Aligarh, India, 202002
    • Aligarh Muslim University
  • Bhubaneshwar, India, 751007
    • Sparsh Hospital, Bhubaneshwar
  • Maharashtra, India, 441108
    • All India Institute of Medical Sciences (AIIMS), Nagpur
  • Puducherry, India, 605006
    • JIPMER
  • Pune, India, 411057
    • Lifepoint Multispecialty Hospital
  • Warangal, India, 506002
    • Mahatma Gandhi Memorial Hospital, Sherpura
  • A.p.
    • Hyderabad, A.p., India, 500 063
      • Osmania General Hospital
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Endolife Specialty Hospitals
    • Vijaywada, Andhra Pradesh, India, 520002
      • Yalamanchi Hospitals and Research centres pvt ltd
  • Gujrat
    • Ahmedabad, Gujrat, India, 380009
      • Navneeth Memorial Hospital
    • Vadodara, Gujrat, India, 390001
      • Govt Medical College
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Ramaiah Memorial Hospital
    • Bangalore, Karnataka, India, 560092
      • Lifecare Hospital and Research Centre
    • Mysuru, Karnataka, India, 570001
      • K R Hospital
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452010
      • TOTALL Diabetes Hormone Institute
  • Maharashtra
    • Goa, Maharashtra, India, 403 202
      • Goa Medical College
    • Kolhapur, Maharashtra, India, 416008
      • Excel Endocrine Centre
    • Mumbai, Maharashtra, India, 400058
      • BSES MG hospital
    • Mumbai, Maharashtra, India, 400012
      • Seth GS Medical College & KEM Hospital
    • Thane, Maharashtra, India, 421004
      • Ashirwad Hospital and Research Centre
    • Wardha, Maharashtra, India, 442001
      • Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Maulana Azad Medical College
  • Punjab
    • Ludhiana, Punjab, India, 141001
      • Dayanand Medical College & Hospital_Ludhiana
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Jawahar Lal Nehru Govt. Medical College
    • Jaipur, Rajasthan, India, 302006
      • Diabetes, Thyroid and Endocrine Centre
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 013
      • M.V.Hospital for Diabetes Pvt. Ltd.
  • Telengana
    • Hyderabad, Telengana, India, 500082
      • Yashoda Hospital
    • Hyderabad, Telengana, India, 500003
      • Gandhi Hospital & Medical college
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226030
      • Medanta Lucknow Hospital
  • West Bengal
    • Kolkata,, West Bengal, India, 700053
      • BP Poddar Hospital
• Malaysia
  • Bintulu, Malaysia, 97000
    • Klinik Kesihatan Bintulu
  • Ipoh, Malaysia, 30450
    • Klinik Kesihatan Greentown Ipoh
  • Kuala Lumpur, Malaysia, 56100
    • Klinik Kesihatan Cheras Baru
  • Melaka, Malaysia, 75400
    • Hospital Melaka
  • Seri Manjung, Malaysia, 32040
    • Hospital Seri Manjung
  • Temerloh,Pahang, Malaysia, 28000
    • Hospital Sultan Haji Ahmad Shah
  • Miri
    • Sarawak, Miri, Malaysia, 98000
      • Hospital Miri
  • Selangor
    • Rawang, Selangor, Malaysia, 48050
      • Klinik Kesihatan Kuang
• Mexico
  • Veracruz, Mexico, 91900
    • FAICIC S. de R.L. de C.V.
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Medical Care and Research S. A de C.V
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • EME RED Hospitalaria
• Poland
  • Bydgoszcz, Poland, 85-605
    • CENTRUM MEDYCZNE INTERCOR Sp. z o.o.
  • Chorzów, Poland, 41-500
    • Diab Serwis Popenda Spółka Jawna
  • Grudziadz, Poland, 86-300
    • NZOZ Euromedica
  • Olsztyn, Poland, 10-117
    • Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
  • Opole, Poland, 45-301
    • ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna
  • Poznań, Poland, 61-853
    • NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne OPOROW
  • Łódź, Poland, 91-053
    • Centra Medyczne Medyceusz Sp. z o.o.
  • Lodzkie
    • Skierniewice, Lodzkie, Poland, 96-100
      • Clinmedica Research sp. z o.o.
  • Masovian
    • Siedlce, Masovian, Poland, 08-110
      • ETG Siedlce
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-879
      • NZOZ Vita-Diabetica Malgorzata Buraczyk
  • Łódzkie
    • Piotrków Trybunalski, Łódzkie, Poland, 97-300
      • Trialmed CRS
• Romania
  • Braila, Romania, 810197
    • Clinica Grivitei 224 S.R.L.
  • Bucharest, Romania, 013764
    • SC Nutrilife SRL
  • Bucuresti, Romania, 050913
    • Diabet Med SRL
  • Ploiesti, Romania, 100561
    • S.C. Dianutrilife Medica S.R.L.
  • Satu-Mare, Romania, 440055
    • Clinica Korall S.R.L. Satu Mare
  • Bucurestii
    • Bucharest, Bucurestii, Romania, 020475
      • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
  • Mures
    • Targu Mures, Mures, Romania, 540142
      • Sc Mediab Srl
    • Tirgu Mures, Mures, Romania, 540142
      • Sc Mediab Srl
• Serbia
  • RS
    • Belgrade, RS, Serbia, 11050
      • Healthcare centre Zvezdara
    • Kragujevac, RS, Serbia, 34000
      • Healthcare centre Kragujevac
    • Nis, RS, Serbia, 18000
      • Healthcare centre Nis
• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Songkla, Thailand, 90110
    • Songklanagarind Hospital
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital
  • Pathum Thani
    • Klong Luang, Pathum Thani, Thailand, 12120
      • Thammasat University Hospital
• United States
  • Texas
    • Waco, Texas, United States, 76708
      • Hillcrest Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide 25 mg; Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.	Drug: Semaglutide; Administered as oral tablets.
Experimental: Semaglutide 50 mg; Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.	Drug: Semaglutide; Administered as oral tablets.
Experimental: Empagliflozin 25 mg; Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.	Drug: Empagliflozin; Administered as oral tablets.
Experimental: Metformin 2000 mg; Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.	Drug: Metformin; Administered as oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated haemoglobin (HbA1c)	Measured in Percentage (%)-points.	From randomisation (week 0) to week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Measured in kilograms (kg).	From randomisation (week 0) to week 52
Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/L).	From randomisation (week 0) to week 52
Change in 7 point self measured plasma glucose (SMPG) mean profile	Measured in mmol/L.	From randomisation (week 0) to week 52
Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments	Measured in mmol/L.	From randomisation (week 0) to week 52
Relative change in body weight	Measured in Percentage (%).	From randomisation (week 0) to week 52
Change in waist circumference	Measured in centimeters (cm).	From randomisation (week 0) to week 52
HbA1c less than or equal to (≤) 6.5% (Yes/No)	Measured as count of participants.	At week 52
HbA1c less than (<) 7% (Yes/No)	Measured as count of participants.	At week 52
Body weight reduction greater than equal to ( ≥) 5% (Yes/No)	Measured as count of participants.	At week 52
Body weight reduction ≥10% (Yes/No)	Measured as count of participants.	At week 52
Body weight reduction ≥15% (Yes/No)	Measured as count of participants.	At week 52
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)	Measured as count of participants.	At week 52
Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From randomisation (week 0) to week 52
Change in diastolic blood pressure	Measured in mmHg.	From randomisation (week 0) to week 52
Change in High-sensitivity C-reactive protein (hsCRP)	Measured in milligrams per liter (mg/L).	From randomisation (week 0) to week 52
Time to rescue medication	Measured in days.	From randomisation (week 0) to week 104
Change in HbA1c	Measured in %-points.	From randomisation (week 0) to week 104
Change in body weight	Measured in kg.	From randomisation (week 0) to week 104
Change in FPG	Measured in mmol/L.	From randomisation (week 0) to week 104
Change in 7 point SMPG mean profile	Measured in mmol/L.	From randomisation (week 0) to week 104
Change in 7-point SMPG mean post prandial increments	Measured in mmol/L	From randomisation (week 0) to week 104
Relative change in body weight	Measured in Percentage.	From randomisation (week 0) to week 104
Change in waist circumference	Measured in cm.	From randomisation (week 0) to week 104
HbA1c ≤6.5% (Yes/No)	Measured as count of participants.	At week 104
HbA1c <7.0% (Yes/No)	Measured as count of participants.	At week 104
Body weight reduction ≥5% (Yes/No)	Measured as count of participants.	At week 104
Body weight reduction ≥10% (Yes/No)	Measured as count of participants.	At week 104
Body weight reduction ≥15% (Yes/No)	Measured as count of participants.	At week 104
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)	Measured as count of participants.	At week 104
Change in systolic blood pressure	Measured in mmHg.	From randomisation (week 0) to week 104
Change in diastolic blood pressure	Measured in mmHg.	From randomisation (week 0) to week 104
Change in hsCRP	Measured in mg/L.	From randomisation (week 0) to week 104
Treatment emergent adverse events	Measured as count of events.	From randomisation (week 0) to week 52
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes	Measured as count of episodes.	From randomisation (week 0) to week 52
Treatment emergent adverse events	Measured as count of events.	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.	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.	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.	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).	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.	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.	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.	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).	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.	From randomisation (week 0) to week 104

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2024
• Primary Completion (Estimated): January 24, 2025
• Study Completion (Estimated): May 28, 2027

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Empagliflozin
• Other Study ID Numbers: NN9924-7663; U1111-1291-4976 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No