A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— CONFIDENCE  

Official title:

A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254002
• Other study ID #: 21839
• Secondary ID: 2023-506981-30-0
• Status: Recruiting
• Phase: Phase 2
• Start date: June 23, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine. In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone. Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times. The study team will: - collect blood and urine samples - check the participants' vital signs - do a physical examination including height and weight - check the participants' heart health by using an electrocardiogram (ECG) - monitor the participants' blood pressure - ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 807
• Est. completion date: February 28, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant with a clinical diagnosis of chronic kidney disease (CKD) and the

following:

• In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
• In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
• 100 =UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
• Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
• Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.

Exclusion Criteria:

• Participants with type 1 diabetes (T1D).
• Participant with hepatic insufficiency classified as Child-Pugh C.
• Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90 mmHg.
• Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
• Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
• Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
• Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Finerenone (BAY94-8862 ) 10 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: <60 mL/min/1.73 m2
• Empagliflozin
oral administration, once daily
• Empagliflozin Placebo
Matching placebo to empagliflozin oral administration, once daily
• Finerenone (BAY94-8862 ) 20 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: =60 mL/min/1.73 m2
• Finerenone Placebo
Matching Placebo to Finerenone oral administration once daily

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst	Aalst
Belgium	UZ Antwerpen	Edegem
Belgium	AZ St-Lucas Campus St-Lucas	Gent
Belgium	UZ Gent	Gent
Belgium	Regionaal ZH Jan Yperman Campus Mariaziekenhuis	Ieper
Belgium	AZ Groeninge Campus Kennedylaan	Kortrijk
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU de Charleroi Hôpital civil	Lodelinsart	Hainaut
Belgium	AZ Delta	Roeselare
Canada	LMC Manna Research - Brampton	Brampton	Ontario
Canada	LMC Manna Research - Calgary	Calgary	Alberta
Canada	LMC Manna Research - Thornhill	Concord	Ontario
Canada	LMC Manna Research - Etobicoke	Etobicoke	Ontario
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	Clinical Research Solutions, Inc.	Kitchener	Ontario
Canada	Centricity Research Mirabel Multispecialty	Mirabel	Quebec
Canada	William Osler Health centre, Sakuara Medical	Mississauga	Ontario
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	Recherche GCP Research	Montreal	Quebec
Canada	LMC Manna Research - Ottawa	Nepean	Ontario
Canada	Bluewater Clinical Research Group	Sarnia	Ontario
Canada	LMC Manna Research - Barrie	TBC	Ontario
Canada	LMC Manna Research - Bayview	Toronto	Ontario
Canada	LMC Clinical Research Inc. Montreal	Ville Saint-Laurent	Quebec
Canada	Sameh Fikry Professional Corporation	Waterloo	Ontario
Denmark	Sydvestjysk Sygehus Esbjerg	Esbjerg
Denmark	Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department	Herlev
Denmark	Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department	Holstebro
Denmark	Bispebjerg Hospital	København NV
France	Hôpital François Mitterrand - Dijon	Dijon
France	Center Hospitalier Michallon - Grenoble	La Tronche
France	Hôpital Edouard Herriot - Lyon Cedex	Lyon Cedex
France	Many Locations	Multiple Locations
France	Hopital Carémeau - Nîmes	Nîmes
France	Hôpital Saint Joseph	Paris
Germany	Charité Campus Benjamin Franklin (CBF)	Berlin
Germany	Diabetologische Schwerpunkt Praxis Dortmund	Dortmund	Nordrhein-Westfalen
Germany	ClinPhenomics GmbH&Co. KG	Frankfurt	Hessen
Germany	Diabetes Zentrum Wandsbek	Hamburg
Germany	St. Josefskrankenhaus	Heidelberg	Baden-Württemberg
Germany	Friedrich-Schiller-Uni. Jena	Jena	Thüringen
Germany	Zentrum für Diabetologie und Ernährungsmedizin	Ludwigshafen	Rheinland-Pfalz
Germany	Cardiologicum Pirna / Dresden-Seidnitz	Pirna	Sachsen
India	Mavani Dialysis & Kidney Center	Ahmedabad
India	Manipal Hospital	Bangalore	Karnataka
India	K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre	Belgaum	Karnataka
India	Bangalore Medical College & Research Institute	Bengaluru
India	Dr. Bantwal's Clinic	Bengaluru
India	All India Institute of Medical Sciences	Bhubaneswar	Delhi
India	Government Kilpauk Medical College Hospital	Chennai
India	Sriram Chandra Bhanj Medical College & Hospital	Cuttack
India	Nizam's Institute of Medical Sciences (NIMS)	Hyderabad
India	Eternal Heart Care Centre (EHCC) and Research Institute	Jaipur	Rajasthan
India	Sawami Man Singh (SMS) Medical College & Attached Hospitals	Jaipur
India	G.S.V.M. Medical College	Kanpur	Uttar Pradesh
India	Institute of Post-Graduate Medical Education and Research	Kolkata	West Bengal
India	Government Medical College	Kozhikode
India	Vinaya Hospital and Research Centre (A Unit of KIMS)	Mangalore
India	Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital	Mumbai
India	Asian Kidney Hospital and Medical Centre	Nagapur
India	Government Medical College and Hospital (GMCH) Nagpur	Nagpur
India	Indraprastha Apollo Hospital	New Delhi	Delhi
India	Max Super Speciality Hospital (MSSH) - Saket	New Delhi
India	Grant Medical Foundation - Ruby Hall Clinic (RHC)	Pune
India	Lifepoint Multispecialty Hospital	Pune
India	Krishna Institute Of Medical Science	Secunderabad
India	Osmania General Hospital	Telangana
India	Vedanta Kidney Care	Vadodara
India	King George Hospital	Visakhapatnam	Andhra Pradesh
Israel	Clalit Health Services through HaEmek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Center	Beer Sheva
Israel	Edith Wolfson Medical Center	Holon
Israel	Hadassah University Medical Center (HUMC)	Jerusalem
Israel	Health Corporation of Galilee Medical Center	Nahariya
Israel	Clalit Health Services Rabin Medical Center-Beilinson Campus	Petach Tikva
Israel	DMC - Diabetes Medical Center	Tel Aviv
Israel	Health Corporation of the Ziv Medical Center (R.A.)	Zefat
Italy	ASST Papa Giovanni XXIII	Bergamo	Lombardia
Italy	ASP di Catania	Catania	Sicilia
Italy	Universita Degli Studi "Gabriele d'Annunzio" - Chieti - Centro Scienze dell'Invecchiamento (Centro Studi Sull'Invecchiamento	Chieti
Italy	IRCCS Casa Sollievo della Sofferenza	Foggia	Puglia
Italy	ASL 4 Chiavarese	Genova	Liguria
Italy	ASST Rhodense	Milano	Lombardia
Italy	ASST Santi Paolo e Carlo	Milano	Lombardia
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Ospedale San Raffaele s.r.l.	Milano	Lombardia
Italy	Many Locations	Multiple Locations
Italy	A.O.U. di Parma	Parma	Emilia-Romagna
Italy	A.O.U. Pisana	Pisa	Toscana
Italy	ATS Sardegna - ASSL Olbia	Sassari	Sardegna
Italy	A.O.U. San Luigi Gonzaga	Torino	Piemonte
Italy	A.O.U.I. Verona	Verona	Veneto
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Fukui-ken Saiseikai Hospital	Fukui
Japan	Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital	Fukuoka
Japan	Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office	Hakusan
Japan	Hirohata Naika Clinic	Kitakyushu	Fukuoka
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Saiseikai Matsuyama Hospital	Matsuyama	Ehime
Japan	Many Locations	Multiple Locations
Japan	Naka Kinen Clinic	Naka	Ibaraki
Japan	Jiyugaoka Yamada Internal Medicine Clinic	Obihiro	Hokkaido
Japan	Kyosokai AMC NISHI-UMEDA Clinic	Osaka
Japan	Osaka General Medical Center	Osaka
Korea, Republic of	Korea University Ansan Hospital	Ansan Si, Kyung Ki Do
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggido
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan	Chungcheongnamdo
Korea, Republic of	Chung Nam National University Hospital	Daejeon
Korea, Republic of	Hanyang University Guri Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Incheon St.Mary's Hospital	Incheon	Incheon Gwang''yeogsi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Yonsei University Wonju Christian Hospital	Wonju	Gang''weondo
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department	Dordrecht
Spain	Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition	A Coruna	A Coruña
Spain	Hospital Principe de Asturias	Alcalá de Henares	Madrid
Spain	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital Quironsalud Barcelona | Internal Medicine Department	Barcelona
Spain	Hospital Vithas Sevilla | Endocrinology Department	Castilleja de la Cuesta
Spain	Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial	Ferrol	A Coruña
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital SAS de Jerez de la Frontera	Jerez de la Frontera	Cádiz
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department	Majadahonda
Spain	Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department	Malaga
Spain	H. Costa del Sol (Marbella)	Marbella
Spain	Many Locations	Multiple Locations
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung
Taiwan	Many Locations	Multiple Locations
Taiwan	Far Eastern Memorial Hospital | Nephrology Department	New Taipei City
Taiwan	Taipei Medical University - Shuang Ho Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Dr Nowreen Haq Endocrinology Clinic	Annapolis	Maryland
United States	Randolph Medical Associates	Asheboro	North Carolina
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of North Carolina Kidney Center	Chapel Hill	North Carolina
United States	Cook County Health and Hospital System	Chicago	Illinois
United States	Velocity Clinical Research, Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baliga Family Practice	Columbus	Ohio
United States	Office of Osvaldo A. Brusco, MD	Corpus Christi	Texas
United States	Dunes Clinical Research LLC	Dakota Dunes	South Dakota
United States	Thyroid, Endocrinology, and Diabetes (TED) PA	Dallas	Texas
United States	Florida Kidney Physicians	Delray Beach	Florida
United States	Southeast Kidney Associates	East Point	Georgia
United States	DaVita Clinical Research - Texas	El Paso	Texas
United States	Nephrology Associates Of Northern Illinois And Ind - Fort Wayne	Fort Wayne	Indiana
United States	Eastern Nephrology Associates / Greenville NC	Greenville	North Carolina
United States	Blue Sky, MD/ Lamond Family Medicine	Hendersonville	North Carolina
United States	Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale	Hinsdale	Illinois
United States	Global Kidney Center	Houston	Texas
United States	Victorium Clinical Research	Houston	Texas
United States	East Coast Institute for Research, Inc. - Jacksonville	Jacksonville	Florida
United States	Clinical Research Consultants	Kansas City	Missouri
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Eastern Nephrology Associates - Kinston	Kinston	North Carolina
United States	Healor Primary Care / CCT Research	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada / CCT Research	Las Vegas	Nevada
United States	North Texas Kidney Disease Associates, PLLC	Lewisville	Texas
United States	Somnos Clinical Research	Lincoln	Nebraska
United States	Academic Medical Research Institute	Los Angeles	California
United States	Biopharma Informatic, LLC	McAllen	Texas
United States	DarSalud Care / LifeDOC Research	Memphis	Tennessee
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Desert Clinical Research - CCT Research	Mesa	Arizona
United States	Nola Care Clinical Research	Metairie	Louisiana
United States	Omega Clinical Research Center	Metairie	Louisiana
United States	Circuit Clinical/Crystal Run	Middletown	New York
United States	Meridian Clinical Research- Norfolk	Norfolk	Nebraska
United States	Northridge Hospital	Northridge	California
United States	West Orange Endocrinology & Clinical Research	Ocoee	Florida
United States	Advent Health	Orlando	Florida
United States	South Shore Nephrology	Plymouth	Massachusetts
United States	Innovative Research Institute	Port Charlotte	Florida
United States	Lake Michigan Nephrology	Saint Joseph	Missouri
United States	St. Louis Heart & Vascular, PC	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Salem VA Medical Center	Salem	Virginia
United States	Olympus Family Medicine	Salt Lake City	Utah
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	University of Texas Health Science Center	San Antonio	Texas
United States	University of Texas Health Science Center	San Antonio	Texas
United States	Meridian Clinical Research- Savannah	Savannah	Georgia
United States	MultiCare Rockwood Clinic Diabetes & Endocrinology Center	Spokane	Washington
United States	Southwest Kidney Institute, PLC	Surprise	Arizona
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Oakland Medical Center	Troy	Michigan
United States	Touro University California	Vallejo	California
United States	Versailles Family Medicine	Versailles	Kentucky
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  France,  Germany,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone	Urinary albumin to-creatinine ratio (UACR)	Up to 180 days
Primary	Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone		Up to 180 days
Primary	Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone		Upto 180 days
Primary	Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone		Up to 180 days
Secondary	Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)		Up to 210 days
Secondary	Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)		Up to 210 days
Secondary	Relative change in UACR category (>30%, >40%, >50%) at 180 days		Up to 180 days
Secondary	Ratio of change from baseline in eGFR at 30 days	estimated glomerular filtration rate (eGRF)	Up to 30 days
Secondary	eGFR decline greater than 30% at 30 days from baseline		Up to 30 days
Secondary	Ratio of change in eGFR at 180 days and 210 days from Day 30		Up to 210 days
Secondary	Proportion of participants with of acute kidney injury (AKI) events	AKI is defined as any of the following: An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or; An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or; A urine volume less than 0.5 ml/kg/h for 6 hours	Up to 180 days
Secondary	Total number of AKI events		Up to 180 days
Secondary	Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ =6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])	serum/plasma potassium (k+)	Up to 180 days
Secondary	Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ =6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])		Up to 180 days
Secondary	Change from baseline in K+		Up to 180 days
Secondary	Proportion of participants with severe hypoglycemia events	Severe hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).	Up to 180 days
Secondary	Total number of events of severe hypoglycemia events		Up to 180 days
Secondary	Proportion of participants with symptomatic hypotension events		Up to 180 days
Secondary	Total number of symptomatic hypotension events		Up to 180 days
Secondary	Proportion of participants with genital mycotic events		Up to 180 days
Secondary	Total number of genital mycotic events		Up to 180 days
Secondary	Proportion of participants with ketoacidosis events		Up to 180 days
Secondary	Total number of ketoacidosis events		Up to 180 days
Secondary	Proportion of participants with necrotizing fasciitis of the perineum events		Up to 180 days
Secondary	Total number of necrotizing fasciitis of the perineum events		Up to 180 days
Secondary	Proportion of participants with urosepsis and pyelonephritis events		Up to 180 days
Secondary	Total number of urosepsis and pyelonephritis events		Up to 180 days

External Links

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