Type 2 Diabetes Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
| Verified date | May 2024 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.
| Status | Completed |
| Enrollment | 986 |
| Est. completion date | May 15, 2024 |
| Est. primary completion date | May 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin - Are receiving =10 units of basal insulin per day and =110 units per day at screening - Have HbA1c value of 6.5% - 10% inclusive, at screening - Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²) - Have been treated with one of the following stable insulin regimens at least 90 days prior to screening: - once daily U100 or U200 of insulin degludec - once daily U100 or U300 of insulin glargine - once or twice daily U100 of insulin detemir, or - once or twice daily human insulin NPH - acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following: - dipeptidyl peptidase (DPP-4) IV inhibitors - SGLT2 inhibitors - metformin - alphaglucosidase inhibitors or, - Glucagon-Like Peptide-1 (GLP-1) receptor agonists - Participants must be willing to stay on stable dose throughout the study Exclusion Criteria: - Have Type 1 diabetes mellitus - Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD) - Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²) - Have active or untreated malignancy - Are pregnant - Have a significant weight gain or loss the past 3 months - Have received anytime in the past 6 months, any of the following insulin therapies: - prandial insulin - insulin mixtures - inhaled insulin - U-500 insulin, or - continuous subcutaneous insulin infusion therapy - Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months: - acute myocardial infarctions - cerebrovascular accident (stroke), or - coronary bypass surgery - Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEMEDIC | Buenos Aires | |
| Argentina | Centro Médico Viamonte | Buenos Aires | Ciudad Aut |
| Argentina | Mautalen Salud e Investigación | Buenos Aires | Ciudad Aut |
| Argentina | Instituto Centenario | Caba | Ciudad Autónoma De Buenos Aire |
| Argentina | Centro Medico Privado CEMAIC | Capital | Córdoba |
| Argentina | Consultorio de Investigación Clínica EMO SRL | Ciudad Autonoma de Buenos Aire | Buenos Air |
| Argentina | Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aire | Buenos Aires |
| Argentina | CENUDIAB | Ciudad Autónoma de Buenos Aire | |
| Argentina | Stat Research S.A. | Ciudad Autónoma de Buenos Aire | Buenos Air |
| Argentina | Centro Diabetológico Dr. Waitman | Córdoba | |
| Argentina | CIPADI - Centro Integral de Prevencion y Atencion en Diabetes | Godoy Cruz | Mendoza |
| Argentina | Instituto de Investigaciones Clínicas Mar del Plata | Mar del Plata | Buenos Aires |
| Argentina | Instituto Médico Catamarca IMEC | Rosario | Santa Fe |
| Argentina | Go Centro Medico San Nicolás | San Nicolas | Buenos Aires |
| Hungary | DRC Gyógyszervizsgáló Központ | Balatonfüred | Veszprém |
| Hungary | Strazsahegy Medicina Bt. | Budapest | |
| Hungary | Szent János Kórház | Budapest | |
| Hungary | Szent Margit Rendelointézet | Budapest | |
| Hungary | Kanizsai Dorottya Korhaz | Nagykanizsa | Zala |
| Hungary | Zala Megyei Szent Rafael Kórház | Zalaegerszeg | Zala |
| Japan | Tokyo-Eki Center-building Clinic | Chuo Ku | Tokyo |
| Japan | Fukuwa Clinic | Chuo-ku | Tokyo |
| Japan | Medical Corporation Chiseikai Tokyo Center Clinic | Chuo-ku | Tokyo |
| Japan | The Institute of Medical Science, Asahi Life Foundation | Chuo-ku | Tokyo |
| Japan | Matoba Internal Medicine Clinic | Ebina | Kanagawa |
| Japan | Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa |
| Japan | Shiraiwa Medical Clinic | Kashiwara | Osaka |
| Japan | Jinnouchi Hospital | Kumamoto | |
| Japan | Tokuyama Clinic | Mihama-ku,Chiba City | Chiba |
| Japan | Kozawa Eye Hospital and Diabetes Center | Mito | Ibaraki |
| Japan | Nakamoto Internal Medicine Clinic | Mito | Ibaraki |
| Japan | Heiwadai Hospital | Miyazaki | |
| Japan | Abe Clinic | Oita | |
| Japan | AMC Nishiumeda Clinic | Osaka | |
| Japan | Oyama East Clinic | Oyama | Tochigi |
| Japan | Shimizu Clinic Fusa | Saitama-shi | Saitama |
| Japan | Yuri Ono Clinic | Sapporo | Hokkaido |
| Japan | Takatsuki Red Cross Hospital | Takatsuki | Osaka |
| Japan | Noritake Clinic | Ushiku | Ibaraki |
| Japan | Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic | Yamato-shi | Kanagawa |
| Korea, Republic of | Korea University Ansan Hospital | Ansan-si | Kyonggi-do |
| 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 | Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyongsangbuk-do |
| Korea, Republic of | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Hallym University Kangnam Sacred Heart Hospital | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Inje University Sanggye Paik Hospital | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Kyung Hee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | Seoul-teuk |
| Korea, Republic of | Ulsan University Hospital | Ulsan | Ulsan-Kwangyokshi |
| Korea, Republic of | Yonsei University-Wonju Severance Christian Hospital | Wonju | Kang-won-do |
| Poland | Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomorskie |
| Poland | NZOZ Diab-Endo-Met | Krakow | Malopolskie |
| Poland | Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Lódzkie |
| Poland | CenterMed Lublin NZOZ | Lublin | Lubelskie |
| Poland | Gabinety TERPA | Lublin | Lubelskie |
| Poland | NZOZ Medica | Lublin | Lubelskie |
| Poland | IRMED | Piotrkow Trybunalski | Lódzkie |
| Poland | Gaja Poradnie Lekarskie Maciej Wiza | Poznan | Wielkopolskie |
| Poland | OMEDICA Medical Center | Poznan | Wielkopolskie |
| Poland | NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki | Ruda Slaska | Slaskie |
| Poland | Private Practice - Dr. Robert Witek | Tarnów | Malopolskie |
| Puerto Rico | GCM Medical Group, PSC - Hato Rey Site | San Juan | |
| Puerto Rico | Mgcendo Llc | San Juan | |
| Slovakia | Diacrin .s.ro. | Bratislava | |
| Slovakia | ENDIAMED s.r.o | Dolny Kubin | Žilinský Kraj |
| Slovakia | Human Care s.r.o. | Kosice | Košický Kraj |
| Slovakia | MediVet s.r.o. | Malacky | Bratislavský Kraj |
| Slovakia | DIA-MED CENTRUM s.r.o. | Puchov | |
| Slovakia | MEDI-DIA s.r.o. | Sabinov | Prešovský Kraj |
| Slovakia | Areteus s.r.o. | Trebisov | Košický Kraj |
| Spain | CHUAC-Complejo Hospitalario Universitario A Coruña | A Coruña | A Coruña [La Coruña] |
| Spain | Centro Periférico de Especialidades Bola Azul | Almeria | Almería |
| Spain | Hospital Universitario de La Ribera | Alzira | Valenciana, Comunitat |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | Andalucía |
| Spain | Clínica Juaneda | Palma de Mallorca | Balears [Baleares] |
| Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
| Spain | Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Sevilla | |
| Spain | Hospital Quiron Infanta Luisa | Sevilla | Andalucía |
| Spain | Vithas Hospital Sevilla | Seville | Sevilla |
| Spain | Hospital General Universitario de Valencia | Valencia | Valenciana, Comunitat |
| Taiwan | Fu Jen Catholic University Hospital | New Taipei | |
| Taiwan | Chung Shan Medical University Hospital | Taichung City | Taichung |
| Taiwan | Taichung Veterans General Hospital | Taichung City | Taichung |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | Chi Mei Medical Center | Tainan City | Tainan |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| United States | Albany Medical College, Division of Community Endocrinology | Albany | New York |
| United States | Gadolin Research | Beaumont | Texas |
| United States | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania |
| United States | Aventiv Research Inc | Columbus | Ohio |
| United States | John Muir Physician Network Research Center | Concord | California |
| United States | Dallas Diabetes Research Center | Dallas | Texas |
| United States | AMCR Institute | Escondido | California |
| United States | Lillestol Research | Fargo | North Dakota |
| United States | SKY Clinical Research Network Group - Hall | Fayette | Mississippi |
| United States | Encore Medical Research | Hollywood | Florida |
| United States | Biopharma Informatic, LLC | Houston | Texas |
| United States | Juno Research | Houston | Texas |
| United States | National Research Institute - Huntington Park | Huntington Park | California |
| United States | Rocky Mountain Clinical Research | Idaho Falls | Idaho |
| United States | Scripps Whittier Diabetes Institute | La Jolla | California |
| United States | Palm Research Center Tenaya | Las Vegas | Nevada |
| United States | Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia |
| United States | Medical Investigations | Little Rock | Arkansas |
| United States | L-MARC Research Center | Louisville | Kentucky |
| United States | Southern Endocrinology Associates | Mesquite | Texas |
| United States | New Horizon Research Center | Miami | Florida |
| United States | HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota |
| United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
| United States | NYC Research | New York | New York |
| United States | Intend Research, LLC | Norman | Oklahoma |
| United States | West Orange Endocrinology | Ocoee | Florida |
| United States | Diabetes Associates Medical Group | Orange | California |
| United States | Jefferson Clinical Research Institute (JCRI) | Philadelphia | Pennsylvania |
| United States | Rainier Clinical Research Center | Renton | Washington |
| United States | Endocrine and Metabolic Consultants | Rockville | Maryland |
| United States | Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas |
| United States | Consano Clinical Research, LLC | Shavano Park | Texas |
| United States | Clinvest Research LLC | Springfield | Missouri |
| United States | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan |
| United States | University Clinical Investigators, Inc. | Tustin | California |
| United States | Preferred Primary Care Physicians | Uniontown | Pennsylvania |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Hungary, Japan, Korea, Republic of, Poland, Puerto Rico, Slovakia, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Hemoglobin A1c (HbA1c) | Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin. | Baseline, Week 26 | |
| Secondary | Nocturnal Hypoglycemia Event Rate | The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78. | Baseline to Week 78 | |
| Secondary | Time in Range | Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session. | Week 22 to Week 26 | |
| Secondary | Change from Baseline in Fasting Glucose | Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). | Baseline, Week 26 | |
| Secondary | Weekly Insulin dose | The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary. | Week 26 | |
| Secondary | Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate | The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase. | Baseline to Week 78 | |
| Secondary | Change from Baseline in Body Weight | Change from baseline in body weight | Baseline, Week 78 | |
| Secondary | Time in Hypoglycemia Range | Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL measured during the CGM session. | Week 22 to Week 26 | |
| Secondary | Time in Hyperglycemia Range | Time in hyperglycemia range defined as time in hyperglycemia with glucose >180 mg/dL measured during the CGM session. | Week 22 to Week 26 | |
| Secondary | Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) | TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment. | Baseline, Week 26 | |
| Secondary | Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) | DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia. | Baseline, Week 26 | |
| Secondary | Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) | DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia. | Baseline, Week 78 |
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