Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study

Status: Recruiting
Location: See all (139) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a dummy substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Female of non-childbearing potential, or male.

⁃ For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.

• Age 18 years or above at the time of signing the informed consent.

• Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.

⁃ HbA1c of 6.5 percentage (%)-10.5 percentage (%) \[48 - 91 millimoles per mole (mmol/mol)\] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (\<)6.5 percentage (%) \[\<48 mmol/mol\] if not diagnosed with type 2 diabetes mellitus.

• BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m\^2) at screening.

• Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (≥) 15 and less than (\<) 90 mL/min/1.73 m\^2.

• Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (\<) 5000 milligram per gram (mg/g).

• Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

Locations
United States
California
N America Res Inst - San Dimas
ACTIVE_NOT_RECRUITING
San Dimas
NorCal Endocrinology and Internal Medicine
ACTIVE_NOT_RECRUITING
San Ramon
Colorado
Rocky Mount Reg VA Med-DN
COMPLETED
Aurora
Florida
Northeast Research Institute
ACTIVE_NOT_RECRUITING
Fleming Island
Encore Medical Research LLC
ACTIVE_NOT_RECRUITING
Hollywood
Northeast Research Institute
ACTIVE_NOT_RECRUITING
Saint Augustine
Clinical Research of Cent FL
COMPLETED
Winter Haven
Illinois
Endeavor Health
COMPLETED
Skokie
Indiana
Velocity Clin. Res Valparaiso
ACTIVE_NOT_RECRUITING
Valparaiso
Michigan
Elite Research Center
COMPLETED
Flint
Missouri
Clinical Research Consultants
ACTIVE_NOT_RECRUITING
Kansas City
North Carolina
Carteret Medical Group
ACTIVE_NOT_RECRUITING
Morehead City
Brookview Hills Research Associates, LLC
ACTIVE_NOT_RECRUITING
Winston-salem
New York
Albany Medical College
ACTIVE_NOT_RECRUITING
Albany
Texas
Davita Clinical Research
ACTIVE_NOT_RECRUITING
El Paso
Clinical Advancement Center
ACTIVE_NOT_RECRUITING
San Antonio
Tekton Research
COMPLETED
San Antonio
Washington
Providence Medical Research Center
ACTIVE_NOT_RECRUITING
Spokane
Other Locations
Argentina
Centro de Investigaciones Metabólicas
ACTIVE_NOT_RECRUITING
City Of Buenos Aires
Instituto de Cardiología de Corrientes
ACTIVE_NOT_RECRUITING
Corrientes
Centro Médico CIMEL
ACTIVE_NOT_RECRUITING
Lanús Este
Instituto de Investigaciones Clinicas Mar Del Plata
ACTIVE_NOT_RECRUITING
Mar Del Plata
Renalida
ACTIVE_NOT_RECRUITING
Mar Del Plata
Australia
Castle Hill Medical Centre
ACTIVE_NOT_RECRUITING
Castle Hill
Heart of Australia
ACTIVE_NOT_RECRUITING
Chelmer
Gosford Renal Research
ACTIVE_NOT_RECRUITING
Gosford
Melbourne Renal Research Group
NOT_YET_RECRUITING
Reservoir
Sunshine Hospital - Western Centre for Health Research and Education
ACTIVE_NOT_RECRUITING
St Albans
Brazil
Centro de Diabetes Curitiba
ACTIVE_NOT_RECRUITING
Curitiba
Instituto Pró-Renal Brasil
ACTIVE_NOT_RECRUITING
Curitiba
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
ACTIVE_NOT_RECRUITING
Curitiba
Irmandade da Santa Casa de Misericórdia de Porto Alegre
ACTIVE_NOT_RECRUITING
Porto Alegre
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
ACTIVE_NOT_RECRUITING
São Paulo
Bulgaria
SRH - Zdrave EAD
ACTIVE_NOT_RECRUITING
Bankya
Medical centre Zdrave 1 OOD
ACTIVE_NOT_RECRUITING
Kozloduy
Nader Yabrudi - ASMPVBE Individual practice
ACTIVE_NOT_RECRUITING
Smolyan
Medical Centre Acad. Iv. Penchev EOOD
COMPLETED
Sofia
Medical Centre Acad. Iv. Penchev EOOD
ACTIVE_NOT_RECRUITING
Sofia
UMHAT Sofiamed EAD
ACTIVE_NOT_RECRUITING
Sofia
UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases
ACTIVE_NOT_RECRUITING
Sofia
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
ACTIVE_NOT_RECRUITING
Sofia
UMHAT Sveta Marina EAD, Clinic of Internal Diseases
ACTIVE_NOT_RECRUITING
Varna
India
MS Ramaiah
NOT_YET_RECRUITING
Bengaluru
Endolife Specialty Hospitals
NOT_YET_RECRUITING
Guntur
Diabetes Research Center, Hyderabad
NOT_YET_RECRUITING
Hyderabad
Nizams Institute of Medical Science
NOT_YET_RECRUITING
Hyderabad
Diabetes, Thyroid and Endocrine Centre
NOT_YET_RECRUITING
Jaipur
SMS Medical College & Hospital
NOT_YET_RECRUITING
Jaipur
Government Medical College, Kozhikode
NOT_YET_RECRUITING
Kozhikode
Italy
Azienda Ospedaliera Papa Giovanni XXIII
COMPLETED
Bergamo
A.O.U. Bologna_ Policlinico S.Orsola Malpighi
ACTIVE_NOT_RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
ACTIVE_NOT_RECRUITING
Brescia
Università degli studi G. D'Annunzio Chieti Pescara - CAST
ACTIVE_NOT_RECRUITING
Chieti
ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia
ACTIVE_NOT_RECRUITING
L’aquila
Azienda Ospedaliera Luigi Sacco
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
NOT_YET_RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCS
ACTIVE_NOT_RECRUITING
Roma
Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
ACTIVE_NOT_RECRUITING
Aichi
Naka Kinen Clinic_Internal medicine
ACTIVE_NOT_RECRUITING
Ibaraki
Naka Kinen Clinic_Internal medicine
RECRUITING
Ibaraki
Fujisawa City Hospital_Kidney internal medicine
RECRUITING
Kanagawa
Fujisawa City Hospital_Kidney internal medicine
COMPLETED
Kanagawa
Higashijujo Sakai Diabetes Clinic_Internal Medicine
ACTIVE_NOT_RECRUITING
Kita-ku, Tokyo
Seino Internal Medicine Clinic_Internal medicine
ACTIVE_NOT_RECRUITING
Koriyama-shi, Fukushima
Hanyu General Hospital_Internal Medicine
COMPLETED
Saitama
Koshigaya Municipal Hospital_Internal medicine
ACTIVE_NOT_RECRUITING
Saitama
Shinden Higashi Clinic
RECRUITING
Sendai-shi, Miyagi
Shinden Higashi Clinic_Internal medicine
ACTIVE_NOT_RECRUITING
Sendai-shi, Miyagi
Omihachiman Community Medical Center_Nephrology
RECRUITING
Siga
Omihachiman Community Medical Center_Nephrology
ACTIVE_NOT_RECRUITING
Siga
Fukuwa Clinic
RECRUITING
Tokyo
Fukuwa Clinic_Internal Medicine
RECRUITING
Tokyo
Fukuwa Clinic_Internal Medicine
ACTIVE_NOT_RECRUITING
Tokyo
Kato Clinic of Internal Medicine
RECRUITING
Tokyo
Kato Clinic of Internal Medicine_Internal Medicine
ACTIVE_NOT_RECRUITING
Tokyo
Tokyo-Eki Center-building Clinic_Internal Medicine
ACTIVE_NOT_RECRUITING
Tokyo
Malaysia
Hospital Pulau Pinang
ACTIVE_NOT_RECRUITING
George Town
Hospital Raja Permaisuri Bainun Ipoh
ACTIVE_NOT_RECRUITING
Ipoh
Hospital Universiti Sains Malaysia
ACTIVE_NOT_RECRUITING
Kota Bharu, Kelantan
Prince Court Medical Centre
ACTIVE_NOT_RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
ACTIVE_NOT_RECRUITING
Lembah Pantai
Hospital Melaka
ACTIVE_NOT_RECRUITING
Malacca
Hospital Miri
ACTIVE_NOT_RECRUITING
Miri
Hospital Sibu
ACTIVE_NOT_RECRUITING
Sibu
Hospital Sungai Buloh
ACTIVE_NOT_RECRUITING
Sungai Buloh
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Bialystok
Uniwersytecki Szpital Kliniczny w Bialymstoku
ACTIVE_NOT_RECRUITING
Bialystok
Nowy Szpital Sp. z o.o.
NOT_YET_RECRUITING
Gmina Świecie
Nowy Szpital Sp. z o.o.
ACTIVE_NOT_RECRUITING
Gmina Świecie
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
COMPLETED
Katowice
SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
ACTIVE_NOT_RECRUITING
Lodz
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Lodzi
NOT_YET_RECRUITING
Lodz
Terpa Sp. z o.o. Sp. k.
RECRUITING
Lublin
Terpa Sp. z o.o. Sp. k.
ACTIVE_NOT_RECRUITING
Lublin
Zanamed Medical Clinic Sp. z o.o.
COMPLETED
Lublin
Wojewodzki Szpital Specjalistyczny w Olsztynie
COMPLETED
Olsztyn
Formed 2 Sp. z o.o.
NOT_YET_RECRUITING
Oświęcim
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
NOT_YET_RECRUITING
Szczecin
Szpitale Tczewskie S.A.
NOT_YET_RECRUITING
Tczew
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
ACTIVE_NOT_RECRUITING
Warsaw
Kardio Life - Tomasz Borkowski
ACTIVE_NOT_RECRUITING
Włocławek
Centrum Medyczne Oporow
COMPLETED
Wroclaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
NOT_YET_RECRUITING
Zabrze
Republic of Korea
Pusan National University Hospital
ACTIVE_NOT_RECRUITING
Busan
National Health Insurance Corporation Ilsan Hospital
COMPLETED
Goyang-si
Hallym UMC_Pyeongchon
ACTIVE_NOT_RECRUITING
Gyeonggi-do
Hanyang University GURI Hospital
ACTIVE_NOT_RECRUITING
Gyeonggi-do
Korea University Guro Hospital
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
COMPLETED
Seoul
Spain
Hospital Clinic i Provincial
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Reina Sofia
ACTIVE_NOT_RECRUITING
Córdoba
Hospital Universitario de Getafe
ACTIVE_NOT_RECRUITING
Getafe
Hospital de Bellvitge
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Fundacion Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Fundacion Jiménez Díaz
ACTIVE_NOT_RECRUITING
Madrid
Hospital Clínico San Carlos
ACTIVE_NOT_RECRUITING
Madrid
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
ACTIVE_NOT_RECRUITING
Seville
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
NOT_YET_RECRUITING
Seville
Hospital Universitario Doctor Peset
ACTIVE_NOT_RECRUITING
Valencia
Hospital Universitario Doctor Peset
NOT_YET_RECRUITING
Valencia
Turkey
Adana Şehir Eğitim ve Araştırma Hastanesi
ACTIVE_NOT_RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi-Dahiliye
ACTIVE_NOT_RECRUITING
Ankara
Ankara Sehir Hastanesi Dahiliye Klinigi
RECRUITING
Ankara
Hacettepe Üniversitesi Hastanesi- Nefroloji
COMPLETED
Ankara
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
RECRUITING
Ankara
Gaziantep Üniversitesi Hastanesi- Endokrinoloji
ACTIVE_NOT_RECRUITING
Gaziantep
Gaziantep Universitesi Tip Fakultesi Hastanesi
RECRUITING
Gaziantep
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
ACTIVE_NOT_RECRUITING
Istanbul
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
RECRUITING
Istanbul
Ege Universitesi Hastanesi- Endokrinoloji
ACTIVE_NOT_RECRUITING
Izmir
Ege Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
Erciyes Üniversitesi Hastanesi - Nefroloji
ACTIVE_NOT_RECRUITING
Kayseri
Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
ACTIVE_NOT_RECRUITING
Kocaeli
Kocaeli University Nephrology Department
RECRUITING
Kocaeli
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-09-17
Participants
Target number of participants: 465
Treatments
Experimental: Dosing scheme a: NNC0519-0130
Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme a: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Experimental: Dosing scheme b: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme b: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Experimental: Dosing scheme c: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme c: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Experimental: Dosing scheme d: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme d: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Active_comparator: Dosing scheme e: Semaglutide
Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

Similar Clinical Trials