A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

Diabetes Clinical Trial

— QWINT-2  

Official title:

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05362058
• Other study ID #: 18262
• Secondary ID: I8H-MC-BDCX2021-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 3, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 928
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have diagnosis of T2D according to the World Health Organization Criteria
• Have an HbA1c of 7.0% - 10% inclusive, at screening
• Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study

Exclusion Criteria:

• Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
• Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
• Have had severe hypoglycemia episodes within 6 months prior to screening.
• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
• Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
• acute myocardial infarction
• cerebrovascular accident (stroke), or
• coronary bypass surgery.
• Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
• Have had significant weight gain or loss within 3 months prior to screening, for example, =5%.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin Efsitora Alfa
Administered SC
• Insulin Degludec
Administered SC

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Sao Lucas	Campinas	São Paulo
Brazil	Cline Research Center	Curitiba	Paraná
Brazil	Hospital São Lucas de Copacabana	Rio de Janeiro
Brazil	CPCLIN	Sao Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	LMC Diabetes & Endocrinology	Brampton	Ontario
Canada	9109-0126 Quebec Inc.	Montreal	Quebec
Canada	LMC Manna Research	Ottawa	Ontario
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Centricity Research Etobicoke Endocrinology	Toronto	Ontario
Canada	Fadia El Boreky Medicine	Waterloo	Ontario
China	Beijing Pinggu District Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Cheng Du	Sichuan
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	The First Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Hebei Medical University - Harrison International Peace Hospital	Hengshui Shi	Hebei
China	Jinan Central Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing Shi	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Shanghai Putuo District Center Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin Medical University Zhu Xianyi Memorial Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The Affiliated Jiangyin Hospital of Southeast University Medical College	Wuxi Shi	Jiangsu
China	The First People's Hospital of Yueyang	Yueyang	Hunan
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Czechia	Diacentrum Brandys n.L. s.r.o.	Brandys nad Labem	Praha-vých
Czechia	MUDr. Alena Vachova	Ceske Budejovice	Jihoceský
Czechia	INTENDIA klinika s.r.o.	Chrudim III	Chrudim
Czechia	MUDr. Tomas Edelsberger	Krnov	Moravskoslezský Kraj
Czechia	MUDr. Tomas Hrdina	Opocno	Rychnov Nad Knežnou
Czechia	Diahelp s.r.o	Pardubice V	Pardubice
Czechia	Milan Kvapil s.r.o., Diabetologicka ambulance	Praha	Praha 4
Germany	Universitaetsklinikum Carl Gustav Carus Dresden	Dresden	Sachsen
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	Medizentrum Essen Borbeck	Essen	Nordrhein-Westfalen
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz	Ludwigshafen am Rhein	Rheinland-Pfalz
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Zentrum für klinische Studien	Saint Ingbert	Saarland
Germany	Praxis Sauter & Sauter & Vorbach	Wangen im Allgäu	Baden-Württemberg
Greece	Alexandra Hospital	Athens	Attikí
Greece	Athens Euroclinic	Athens
Greece	Iatriko Paleou Falirou Medical Center	Paleo Faliro	Attikí (Region)
Greece	Thermi Clinic	Thessaloniki	Thessaloníki
Japan	Kumanomae Nishimura Clinic	Arakawa-ku	Tokyo
Japan	Hayashi Diabetes Internal Medicine Clinic	Chigasaki	Kanagawa
Japan	Hasegawa Medical Clinic	Chitose	Hokkaido
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Nippon Kokan Fukuyama Hospital	Fukuyama-shi	Hiroshima
Japan	Hachioji Diabetes Clinic	Hachioji-shi	Tokyo
Japan	Kashiwa City Hospital	Kashiwa	Chiba
Japan	Yoshimura Clinic	Kumamoto
Japan	Tokuyama Clinic	Mihama-ku,Chiba City	Chiba
Japan	MinamiAkatsukaClinic	Mito	Ibaraki
Japan	Tosaki Clinic for Diabetes and Endocrinology	Nagoya-shi	Aichi
Japan	Nakakinen clinic	Naka	Ibaraki
Japan	Abe Clinic	Oita
Japan	Medical Corporation Sato Medical clinic	Ootaku	Tokyo
Japan	Shimizu Clinic Fusa	Saitama-shi	Saitama
Japan	Manda Memorial Hospital	Sapporo	Hokkaido
Japan	Tomonaga Clinic	Shinjuku	Tokyo
Japan	Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa
Korea, Republic of	Kangwon National University Hospital	Chuncheon-si	Kang-won-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Kyonggi-do
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teuk
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Puerto Rico	Centro de Endocrinologia y Nutricion	Caguas
Puerto Rico	Private Practice - Dr. Paola Mansilla-Letelier	Guaynabo
United States	Qualmedica Research	Bowling Green	Kentucky
United States	New England Research Associates, LLC	Bridgeport	Connecticut
United States	East Coast Institute for Research - Canton	Canton	Georgia
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Clarity Clinical Research	East Syracuse	New York
United States	Neighborhood Healthcare Institute of Health	Escondido	California
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Valley Research	Fresno	California
United States	New West Physicians Clinical Research	Golden	Colorado
United States	NorCal Medical Research, Inc	Greenbrae	California
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	Juno Research	Houston	Texas
United States	MedStar Health Research Institute (MedStar Physician Based Research Network)	Hyattsville	Maryland
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Catalina Research Institute, LLC	Montclair	California
United States	Lucas Research, Inc	Morehead City	North Carolina
United States	Intend Research, LLC	Norman	Oklahoma
United States	North Hills Family Medicine/North Hills Medical Research	North Richland Hills	Texas
United States	Jefferson Clinical Research Institute (JCRI)	Philadelphia	Pennsylvania
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Multicare Institute for Research and Innovation	Spokane	Washington
United States	Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative	Springfield	Illinois
United States	Clinvest Research LLC	Springfield	Missouri
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Great Lakes Medical Research, LLC	Westfield	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  China,  Czechia,  Germany,  Greece,  Japan,  Korea, Republic of,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)	Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for the treatment of type 2 diabetes (T2D) in adults.	Baseline, Week 52
Secondary	Change from Baseline in HbA1c	Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants using glucagon-like peptide-1 (GLP-1) receptor agonists	Baseline, Week 52
Secondary	Change from Baseline in HbA1c	Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants not using GLP-1 receptor agonists	Baseline, Week 52
Secondary	Time in Glucose Range	Time in glucose range between 70 and 180 milligram/deciliter inclusive, collected during the continued glucose monitoring session prior to week 52.	Week 48 to Week 52
Secondary	Change from Baseline in Fasting Glucose	Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)	Baseline, Week 52
Secondary	Weekly Insulin Dose	The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.	Baseline, Week 52
Secondary	Level 2 or Level 3 Nocturnal Hypoglycemia Events	The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.	Baseline to Week 52
Secondary	Change from Baseline in Body Weight	Change from baseline in body weight	Baseline, Week 52
Secondary	Time in hypoglycemia range with glucose <54 mg/dL	Time in hypoglycemia with glucose <54 mg/dL measurements collected during continuous glucose monitoring (CGM) sessions collected prior to Week 52	Week 48 to Week 52
Secondary	Time in Hyperglycemia range with glucose >180 mg/dL	Time in hypoglycemia with glucose >180 mg/dL measurements collected during CGM sessions collected prior to Week 52	Week 48 to Week 52
Secondary	Change from Baseline in Treatment-Related IMPACT Measures-Diabetes (TRIM-D)	TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. Each of the 28 items is assessed on a 5-point scale, where higher scores indicate a better health state.	Baseline, Week 52
Secondary	Change from Baseline in Short Form-36 Version 2 Health Survey Acute Form (SF-36)	SF-36 v2 Health Survey Acute form is a participant self-administered measure designed to assess these 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health.; Each domain is scored individually. Scoring of each domain and both summary scores, physical and mental component scores, are norm based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10. Higher scores indicate better levels of function and/or better health.	Baseline, Week 52
Secondary	Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L)	EQ-5D-5L assesses 5 dimensions of health mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The 5L version scores each dimension at 5 levels, no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems.; Each domain score ranges between less than 0 to 1, where negative values are valued as worse than dead, 0 is a health state equivalent to death, and 1 represents perfect health.	Baseline, Week 52

External Links

•   A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)