Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

NCT06083675 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: NN9924-7663U1111-1291-4976
• Study Type: interventional
• Target: N/A
• Locations: 13 countries
• Sites: 100

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  Measured in Percentage (%)-points.

  From randomisation (week 0) to week 52

Secondary Outcomes (44)

• Change in body weight

  From randomisation (week 0) to week 52

• Change in fasting plasma glucose (FPG)

  From randomisation (week 0) to week 52

• Change in 7 point self measured plasma glucose (SMPG) mean profile

  From randomisation (week 0) to week 52

• Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments

  From randomisation (week 0) to week 52

• Relative change in body weight

  From randomisation (week 0) to week 52

Study Arms (4)

Semaglutide 25 mg

EXPERIMENTAL

Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.

Drug: Semaglutide

Semaglutide 50 mg

EXPERIMENTAL

Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.

Drug: Semaglutide

Empagliflozin 25 mg

EXPERIMENTAL

Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.

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.

Drug: Metformin

Interventions

Semaglutide DRUG

Administered as oral tablets.

Semaglutide 25 mg; Semaglutide 50 mg

Empagliflozin DRUG

Administered as oral tablets.

Empagliflozin 25 mg

Metformin DRUG

Administered as oral tablets.

Metformin 2000 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (100)

Hillcrest Family Health Center

Waco, Texas, 76708, United States

Location

Instituto de Ciências Farmacêuticas

Goiânia, Goiás, 74935-330, Brazil

Location

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

CPCLIN - Centro de Pesquisas Clínicas

São Paulo, São Paulo, 01228-200, Brazil

Location

Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.

Kyustendil, 2500, Bulgaria

Location

Diagnostic-Consultative Centre "Sveti Georgi" Eood

Plovdiv, 4002, Bulgaria

Location

"Aipsomcemd - Dr. Petya Georgieva" Eood

Plovdiv, 4018, Bulgaria

Location

''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood

Samokov, 1000, Bulgaria

Location

"Medical center Medishtit Velisia" OOD

Stara Zagora, 6000, Bulgaria

Location

Diagnostic Consulting Center 1 Velingrad EOOD

Velingrad, 4600, Bulgaria

Location

MHAT- Hristo Botev AD

Vratsa, 3000, Bulgaria

Location

Poliklinika SLAVONIJA OSIJEK

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Opca bolnica Karlovac

Karlovac, 47000, Croatia

Location

Specijalna bolnica Krapinske Toplice - Endokrinologija

Krapinske Toplice, 49217, Croatia

Location

Opca bolnica Pula

Pula, 52100, Croatia

Location

Specijalna bolnica Medico

Rijeka, 51000, Croatia

Location

Iatriko Psychicou Private Clinic

Athens, 115 25, Greece

Location

"Laiko" General Hospital of Athens

Athens, GR-11527, Greece

Location

Iatriko Athinon (Athens Medical Canter)

Athens, GR-15125, Greece

Location

Iatriko Athinon 'Palaiou Falirou'

Athens, GR-17562, Greece

Location

University Hospital of Athens ATTIKON

Haidari-Athens, GR-12462, Greece

Location

University General Hospital of Ioannina,Internal Medicine

Ioannina, 45500, Greece

Location

General Hospital of Thessaloniki 'G. Gennimatas

Thessaloniki, GR-54635, Greece

Location

EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

Thessaloniki, GR-54643, Greece

Location

"Thermi" Private Hosital

Thessaloniki, GR-57001, Greece

Location

General Hospital of Thessaloniki "G.Papanikolaou"

Thessaloniki, GR-57010, Greece

Location

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

Budapest, 1089, Hungary

Location

Belinus Bt.

Debrecen, 4025, Hungary

Location

Osmania General Hospital

Hyderabad, A.P., 500 063, India

Location

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, 522001, India

Location

Yalamanchi Hospitals and Research centres pvt ltd

Vijaywada, Andhra Pradesh, 520002, India

Location

Navneeth Memorial Hospital

Ahmedabad, Gujarat, 380009, India

Location

Govt Medical College

Vadodara, Gujarat, 390001, India

Location

Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Lifecare Hospital and Research Centre

Bangalore, Karnataka, 560092, India

Location

K R Hospital

Mysuru, Karnataka, 570001, India

Location

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

Location

Goa Medical College

Goa, Maharashtra, 403 202, India

Location

Excel Endocrine Centre

Kolhāpur, Maharashtra, 416008, India

Location

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

BSES MG hospital

Mumbai, Maharashtra, 400058, India

Location

Ashirwad Hospital and Research Centre

Thane, Maharashtra, 421004, India

Location

Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha

Wardha, Maharashtra, 442001, India

Location

Maulana Azad Medical College

Delhi, New Delhi, 110002, India

Location

Dayanand Medical College & Hospital_Ludhiana

Ludhiana, Punjab, 141001, India

Location

Jawahar Lal Nehru Govt. Medical College

Ajmer, Rajasthan, 305001, India

Location

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, 302006, India

Location

M.V.Hospital for Diabetes Pvt. Ltd.

Chennai, Tamil Nadu, 600 013, India

Location

Gandhi Hospital & Medical college

Hyderabad, Telangana, 500003, India

Location

Yashoda hospital

Hyderabad, Telangana, 500082, India

Location

Medanta Lucknow Hospital

Lucknow, Uttar Pradesh, 226030, India

Location

BP Poddar Hospital

Kolkata, West Bengal, 700053, India

Location

Swasthya Diabetes Care

Ahmedabad, 390013, India

Location

Aligarh Muslim University

Aligarh, 202002, India

Location

Sparsh Hospital, Bhubaneshwar

Bhubaneshwar, 751007, India

Location

All India Institute of Medical Sciences (AIIMS), Nagpur

Maharashtra, 441108, India

Location

JIPMER

Puducherry, 605006, India

Location

Lifepoint Multispecialty Hospital

Pune, 411057, India

Location

Mahatma Gandhi Memorial Hospital, Sherpura

Warangal, 506002, India

Location

Hospital Miri

Sarawak, Miri, 98000, Malaysia

Location

Klinik Kesihatan Kuang

Rawang, Selangor, 48050, Malaysia

Location

Klinik Kesihatan Bintulu

Bintulu, 97000, Malaysia

Location

Klinik Kesihatan Greentown Ipoh

Ipoh, 30450, Malaysia

Location

Klinik Kesihatan Cheras Baru

Kuala Lumpur, 56100, Malaysia

Location

Hospital Melaka

Malacca, 75400, Malaysia

Location

Hospital Seri Manjung

Seri Manjung, 32040, Malaysia

Location

Hospital Sultan Haji Ahmad Shah

Temerloh,Pahang, 28000, Malaysia

Location

Eme Red Hospitalaria

Mérida, Yucatán, 97070, Mexico

Location

Medical Care and Research S. A de C.V

Mérida, Yucatán, 97070, Mexico

Location

FAICIC S. de R.L. de C.V.

Veracruz, 91900, Mexico

Location

ETG Siedlce

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605, Poland

Location

Diab Serwis Popenda Spółka Jawna

Chorzów, 41-500, Poland

Location

NZOZ Euromedica

Grudziądz, 86-300, Poland

Location

Centra Medyczne Medyceusz Sp. z o.o.

Lodz, 91-053, Poland

Location

Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.

Olsztyn, 10-117, Poland

Location

ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna

Opole, 45-301, Poland

Location

NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy

Poznan, 61-853, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Trialmed CRS

Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

Location

Clinmedica Research sp. z o.o.

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

Bucharest, Bucurestii, 020475, Romania

Location

Sc Mediab Srl

Târgu Mureş, Mureș County, 540142, Romania

Location

Clinica Grivitei 224 S.R.L.

Brăila, 810197, Romania

Location

SC Nutrilife SRL

Bucharest, 013764, Romania

Location

Diabet Med SRL

Bucharest, 050913, Romania

Location

S.C. Dianutrilife Medica S.R.L.

Ploieşti, 100561, Romania

Location

Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055, Romania

Location

Healthcare centre Zvezdara

Belgrade, RS, 11050, Serbia

Location

Healthcare centre Kragujevac

Kragujevac, RS, 34000, Serbia

Location

Healthcare centre Nis

Niš, RS, 18000, Serbia

Location

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Thammasat University Hospital

Klong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: January 26, 2024
• Primary Completion: January 24, 2025
• Study Completion (Estimated): May 28, 2027
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

RO (7); BU (7); US (1); MY (8); SE (3); ME (3); TH (7); GR (10); IN (31); HU (2); PL (12); CR (5); BR (4)