Clinical trial NCT05362058: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 928
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.


Eligibility criteria: Inclusion Criteria:

* Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
* Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
* Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
* These antihyperglycemic medications are accepted in the study

  * dipeptidyl peptidase-4 (DPP-4) inhibitors
  * sodium-glucose cotransporter 2 (SGLT2) inhibitors
  * biguanides, such as metformin
  * alpha-glucosidase inhibitors
  * glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
  * Sulfonylureas, or
  * Thiazolidinediones.
* Are insulin naïve.

Exceptions:

* short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes

  * Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).

Exclusion Criteria:

* Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a 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 greater than (\>) 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 a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
* 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, greater than or equal to (≥) 5%.

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis]
timeFrame: Baseline, Week 52
measure: Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis]
timeFrame: Baseline, Week 52
measure: Change From Baseline in HbA1c at Week 52 [Superiority Analysis]
timeFrame: Baseline, Week 52
measure: Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52
timeFrame: Week 48 to Week 52
measure: Change From Baseline in HbA1c at Week 26 [Superiority Analysis]
timeFrame: Baseline, Week 26
measure: Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 22 to Week 26
timeFrame: Week 22 to Week 26
measure: Change From Baseline in Fasting Blood Glucose (FBG)
timeFrame: Baseline, Week 26, Week 52
measure: Glucose Variability
timeFrame: Week 22 to Week 26 and Week 48 to Week 52
measure: Basal Insulin Dose
timeFrame: Week 26 and Week 52
measure: Hypoglycemia Event Rate
timeFrame: Baseline up to Week 52
measure: Nocturnal Hypoglycemia Event Rate
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 26, Week 52
measure: Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L)
timeFrame: Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52
measure: Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)
timeFrame: Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52
measure: Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L)
timeFrame: Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52
measure: Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52
timeFrame: Baseline, Week 26, Week 52
measure: Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores at Week 26 and Week 52
timeFrame: Baseline, Week 26, Week 52
measure: Change From Baseline in EuroQuality of Life (EuroQol) - 5 Dimensions-5 Levels (EQ-5D-5L) Health State Index and EQ Visual Analog Scale (VAS) Scores at Week 26 and Week 52
timeFrame: Baseline, Week 26, Week 52
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Neighborhood Healthcare Institute of Health
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Greenbrae
country: United States
facility: NorCal Medical Research, Inc
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Golden
country: United States
facility: New West Physicians Clinical Research
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Canton
country: United States
facility: East Coast Institute for Research - Canton
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Springfield
country: United States
facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Bowling Green
country: United States
facility: Qualmedica Research
state: Kentucky
city: Hyattsville
country: United States
facility: MedStar Health Research Institute (MedStar Physician Based Research Network)
state: Maryland
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Ridgeland
country: United States
facility: SKY Clinical Research Network Group-Quinn
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: East Syracuse
country: United States
facility: Clarity Clinical Research
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research, LLC
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Jefferson Clinical Research Institute (JCRI)
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Medicine/North Hills Medical Research
state: Texas
city: Spokane
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Cline Research Center
state: Paraná
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital São Lucas de Copacabana
city: Sao Paulo
country: Brazil
facility: CPCLIN
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Brampton
country: Canada
facility: LMC Diabetes & Endocrinology
state: Ontario
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Ottawa
country: Canada
facility: LMC Manna Research
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Toronto
country: Canada
facility: Centricity Research Etobicoke Endocrinology
state: Ontario
city: Waterloo
country: Canada
facility: Fadia El Boreky Medicine
state: Ontario
city: Montreal
country: Canada
facility: 9109-0126 Quebec Inc.
state: Quebec
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Hengshui Shi
country: China
facility: Hebei Medical University - Harrison International Peace Hospital
state: Hebei
city: Harbin
country: China
facility: The First Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Yueyang
country: China
facility: The First People's Hospital of Yueyang
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing Shi
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi Shi
country: China
facility: The Affiliated Jiangyin Hospital of Southeast University Medical College
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Zhu Xianyi Memorial Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Chrudim III
country: Czechia
facility: INTENDIA klinika s.r.o.
state: Chrudim
city: Ceske Budejovice
country: Czechia
facility: MUDr. Alena Vachova
state: Jihočeský
city: Krnov
country: Czechia
facility: MUDr. Tomas Edelsberger
state: Moravskoslezský Kraj
city: Pardubice V
country: Czechia
facility: Diahelp s.r.o
state: Pardubice
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance
state: Praha 4
city: Brandys nad Labem
country: Czechia
facility: Diacentrum Brandys n.L. s.r.o.
state: Praha-vých
city: Opocno
country: Czechia
facility: MUDr. Tomas Hrdina
state: Rychnov Nad Kněžnou
city: Wangen im Allgäu
country: Germany
facility: Praxis Sauter & Sauter & Vorbach
state: Baden-Württemberg
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein-Westfalen
city: Ludwigshafen am Rhein
country: Germany
facility: Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
state: Rheinland-Pfalz
city: Saint Ingbert
country: Germany
facility: Zentrum für klinische Studien
state: Saarland
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Paleo Faliro
country: Greece
facility: Iatriko Paleou Falirou Medical Center
state: Attikí (Region)
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Thessaloniki
country: Greece
facility: Thermi Clinic
state: Thessaloníki
city: Athens
country: Greece
facility: Athens Euroclinic
city: Nagoya-shi
country: Japan
facility: Tosaki Clinic for Diabetes and Endocrinology
state: Aichi
city: Kashiwa
country: Japan
facility: Kashiwa City Hospital
state: Chiba
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Fukuyama-shi
country: Japan
facility: Nippon Kokan Fukuyama Hospital
state: Hiroshima
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Manda Memorial Hospital
state: Hokkaido
city: Mito
country: Japan
facility: MinamiAkatsukaClinic
state: Ibaraki
city: Naka
country: Japan
facility: Nakakinen clinic
state: Ibaraki
city: Chigasaki
country: Japan
facility: Hayashi Diabetes Internal Medicine Clinic
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Saitama-shi
country: Japan
facility: Shimizu Clinic Fusa
state: Saitama
city: Arakawa-ku
country: Japan
facility: Kumanomae Nishimura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Hachioji Diabetes Clinic
state: Tokyo
city: Ootaku
country: Japan
facility: Medical Corporation Sato Medical clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Tomonaga Clinic
state: Tokyo
city: Kumamoto
country: Japan
facility: Yoshimura Clinic
city: Oita
country: Japan
facility: Abe Clinic
city: Chuncheon-si
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Kang-won-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teuk
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Caguas
country: Puerto Rico
facility: Centro de Endocrinologia y Nutricion
city: Guaynabo
country: Puerto Rico
facility: Private Practice - Dr. Paola Mansilla-Letelier
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: