Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Nephropathy
Treatment
Semaglutide
Placebo (Semaglutide)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female.
Age above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to theday of screening.
HbA1c (glycated haemoglobin) below or equal to 9.0 percent (below or equal to 75mmol/mol).
Depending on biopsy/non-biopsy population:
For subjects in the non-biopsy population: Serum creatinine-based eGFR greaterthan or equal to 30 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).
For subjects in the biopsy sub-population: Serum creatinine-based eGFR greaterthan or equal to 40 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).
UACR ( Urinary albumin-to-creatinine ratio ) greater than or equal to 20 and below 5000 mg/g.
Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosteronesystem (RAAS) blocking agent including an angiotensin converting enzyme (ACE)inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment iscontraindicated or not tolerated.Treatment dose must be stable for at least 28 daysprior to screening.
Exclusion
Exclusion Criteria:
Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days priorto screening.
A prior solid organ transplant or awaiting solid organ transplant.
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris ortransient ischaemic attack within 180 days prior to the day of screening.
Presence or history of malignant neoplasms (other than basal or squamous cell skincancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 yearsprior to the day of screening.
Congenital or hereditary kidney diseases including polycystic kidney disease,autoimmune kidney diseases including glomerulonephritis or congenital urinary tractmalformations.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within the past 90 days prior to screening or inthe period between screening and Visit 2. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination.
Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 daysprior to screening. Stable treatment with acetylsalicylic acid for prevention ofcardiovascular events and occasional use of propionic acid derivatives drugs (e.g.ibuprofen) is allowed.
Any contraindication for MRI according to standard checklist used in clinicalroutine, including claustrophobia or metallic foreign bodies, metallic implants,internal electrical devices, or permanent makeup/tattoos that cannot be declared MRcompatible.
Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers).
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Toronto, Ontario M5G 2N2
CanadaActive - Recruiting
UHN-Toronto General Hospital
Toronto, Ontario M5G 2N2
CanadaSite Not Available
Nefrologisk Klinik P 2132
Copenhagen, 2100
DenmarkSite Not Available
Novo Nordisk Investigational Site
Copenhagen, 2100
DenmarkSite Not Available
Novo Nordisk Investigational Site
Herlev, 2730
DenmarkActive - Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
DenmarkSite Not Available
Centre Hospitalier Universitaire Amiens Picardie-Site Sud
AMIENS cedex 1, 80054
FranceSite Not Available
Novo Nordisk Investigational Site
AMIENS cedex 1, 80054
FranceCompleted
Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume
Bois-Guillaume, 76230
FranceSite Not Available
Novo Nordisk Investigational Site
Bois-Guillaume, 76230
FranceActive - Recruiting
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2
Grenoble - Cédex 09, 38043
FranceSite Not Available
Novo Nordisk Investigational Site
Grenoble - Cédex 09, 38043
FranceActive - Recruiting
Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
Reims, 51092
FranceSite Not Available
Novo Nordisk Investigational Site
Reims, 51092
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
Toulouse, 31059
FranceSite Not Available
Novo Nordisk Investigational Site
Toulouse, 31059
FranceActive - Recruiting
Istituto Scientifico San Raffaele
Milano, MI 20132
ItalySite Not Available
Novo Nordisk Investigational Site
Milano, MI 20132
ItalyActive - Recruiting
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
ItalySite Not Available
Novo Nordisk Investigational Site
Bergamo, 24127
ItalyActive - Recruiting
Azienda Ospedaliera di Padova Clin.Med.3
Padova, 35128
ItalySite Not Available
Novo Nordisk Investigational Site
Padova, 35128
ItalyActive - Recruiting
Azienda Ospedaliero - Universitaria Sant'Andrea
Roma, 00189
ItalySite Not Available
Novo Nordisk Investigational Site
Roma, 00189
ItalyActive - Recruiting
In-Vivo Sp. z o.o.
Bydgoszcz, 85-048
PolandSite Not Available
Novo Nordisk Investigational Site
Bydgoszcz, 85-048
PolandActive - Recruiting
Centrum Medyczne "Diabetika"
Radom, 26-600
PolandSite Not Available
Novo Nordisk Investigational Site
Radom, 26-600
PolandActive - Recruiting
Novo Nordisk Investigational Site
Szczecin, 70-111
PolandSuspended
SPSK nr 2 PUM, Kl. Nefrologii, Transplantologii i Ch. Wewn.
Szczecin, 70-111
PolandSite Not Available
Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny
Warszawa, 04-749
PolandSite Not Available
Novo Nordisk Investigational Site
Warszawa, 04-749
PolandActive - Recruiting
Novo Nordisk Investigational Site
Zabrze, 41-800
PolandActive - Recruiting
Prywatny Gabinet Janusz Gumprecht
Zabrze, 41-800
PolandSite Not Available
Maxwell Centre
Durban, KwaZulu-Natal 4001
South AfricaSite Not Available
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal 4092
South AfricaActive - Recruiting
Precise Clinical Solutions (Pty) Ltd
Durban, KwaZulu-Natal 4092
South AfricaSite Not Available
Novo Nordisk Investigational Site
Cape Town, Western Cape 7925
South AfricaActive - Recruiting
Prof Rayner
Cape Town, Western Cape 7925
South AfricaSite Not Available
Prof Rayner_Division of Nephrology
Cape Town, Western Cape 7925
South AfricaSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Novo Nordisk Investigational Site
Barcelona, 08035
SpainActive - Recruiting
Hospital de Bellvitge
Hospitalet de Llobregat, 08907
SpainSite Not Available
Novo Nordisk Investigational Site
Hospitalet de Llobregat, 08907
SpainActive - Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Novo Nordisk Investigational Site
Valencia, 46010
SpainActive - Recruiting
Novo Nordisk Investigational Site
Tucson, Arizona 85724
United StatesSite Not Available
University of Arizona-CaTs
Tucson, Arizona 85724
United StatesSite Not Available
Academic Medical Research Institute
Los Angeles, California 90022
United StatesSite Not Available
Novo Nordisk Investigational Site
Los Angeles, California 90022
United StatesSuspended
N America Res Inst - San Dimas
San Dimas, California 91773
United StatesSite Not Available
Novo Nordisk Investigational Site
San Dimas, California 91773
United StatesActive - Recruiting
Novo Nordisk Investigational Site
Aurora, Colorado 80045
United StatesActive - Recruiting
UC Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Advent Health-Res Inst
Orlando, Florida 32804
United StatesSite Not Available
Novo Nordisk Investigational Site
Orlando, Florida 32804
United StatesActive - Recruiting
Clinical Research Consultants, LLC
Kansas City, Missouri 64111
United StatesSite Not Available
Novo Nordisk Investigational Site
Kansas City, Missouri 64111
United StatesActive - Recruiting
Novo Nordisk Investigational Site
Houston, Texas 77054
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
Prolato Clinical Research Cntr
Houston, Texas 77054
United StatesSite Not Available
Novo Nordisk Investigational Site
Live Oak, Texas 78233
United StatesSite Not Available
NE Clin Res of San Antonio
San Antonio, Texas 78233
United StatesSite Not Available
Novo Nordisk Investigational Site
San Antonio, Texas 78215
United StatesSite Not Available
Sun Research Institute
San Antonio, Texas 78215
United StatesSite Not Available
Novo Nordisk Investigational Site
Seattle, Washington 98195
United StatesActive - Recruiting
Univ of Washington Med Ctr
Seattle, Washington 98195
United StatesSite Not Available
Novo Nordisk Investigational Site
Spokane, Washington 99204
United StatesActive - Recruiting
Providence Medical Research Center
Spokane, Washington 99204
United StatesSite Not Available
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