A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT06192108
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 888
- Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
- Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
- Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization.
- Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
- Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.
- Have Type 1 Diabetes (T1D)
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have an estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73 square meter (m2)
- Have acute or chronic hepatitis
- Have had chronic or acute pancreatitis any time.
- Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 3 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally. Dapagliflozin Dapagliflozin Participants will receive dapagliflozin orally.
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c: (HbA1c) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percentage Change from Baseline in Triglycerides Baseline, Week 40 Change from Baseline in HbA1c Baseline, Week 40 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline Baseline to Week 40 Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline Baseline to Week 40 Percentage Change from Baseline in Total Cholesterol Baseline, Week 40 Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol)) Week 40 Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) Week 40 Percentage Change from Baseline in Body Weight Baseline, Week 40 Change from Baseline in Body Weight Baseline, Week 40 Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol Baseline, Week 40 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 40 Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores Baseline, Week 40 Change from Baseline in Fasting Serum Glucose Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline Baseline to Week 40 Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores Baseline, Week 40
Trial Locations
- Locations (75)
Alliance Research Institute - Canoga Park
🇺🇸Canoga Park, California, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Los Alamitos, California, United States
Wolverine Clinical Trials
🇺🇸Tustin, California, United States
CMR of Greater New Haven, LLC
🇺🇸Hamden, Connecticut, United States
Institute of Endocrinology Diabetes, Health & Hormone
🇺🇸Stockbridge, Georgia, United States
Elite Clinical Trials
🇺🇸Rexburg, Idaho, United States
Accellacare - DuPage
🇺🇸Lombard, Illinois, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Accellacare - Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Essential Medical Research
🇺🇸Tulsa, Oklahoma, United States
Accellacare - Mt Pleasant
🇺🇸Mount Pleasant, South Carolina, United States
Accellacare, US Inc., d/b/a Accellacare of Knoxville
🇺🇸Jefferson City, Tennessee, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
CRS Clinical Research Services Mannheim
🇩🇪Mannheim, Baden-Württemberg, Germany
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
🇩🇪Lingen, Niedersachsen, Germany
Diabetes- und Stoffwechselpraxis Bochum
🇩🇪Bochum, Nordrhein-Westfalen, Germany
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Medizentrum Essen Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
Zentrum fur klinische Forschung - Köln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Institut für Diabetesforschung GmbH Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Praxis Dr. Veronika Wenzl-Bauer
🇩🇪Rehlingen, Saarland, Germany
Zentrum für klinische Studien
🇩🇪Saint Ingbert, Saarland, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Diabetes Zentrum Wilhelmsburg
🇩🇪Hamburg, Germany
Cryptex Investigación Clínica S.A. de C.V.
🇲🇽Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico
ProcliniQ Investigación Clínica SA de CV
🇲🇽Mexico City, Distrito Federal, Mexico
Grupo Ollin Care
🇲🇽Pachuca, Hidalgo, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
🇲🇽Guadalajara, Jalisco, Mexico
Instituto de Diabetes, Obesidad y Nutricion
🇲🇽Cuernavaca, Morelos, Mexico
Invecordis S.C.
🇲🇽Hacienda De Las Palmas, México, Mexico
Cardiolink Clin Trials
🇲🇽Monterrey, Nuevo León, Mexico
Clínica García Flores SC
🇲🇽Monterrey, Nuevo León, Mexico
Servicios Integrales Nova de Monterrey S.A. de C.V.
🇲🇽San Nicolas de los Garza, Nuevo León, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
🇲🇽Culiacan, Sinaloa, Mexico
Consultorio de Medicina Especilizada del Sector Privado
🇲🇽Xalapa, Veracruz, Mexico
Hospital Angeles Xalapa
🇲🇽Xalapa, Veracruz, Mexico
Fundación Cardiovascular de Aguascalientes A.C.
🇲🇽Aguascalientes, Mexico
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
🇲🇽Durango, Mexico
Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
🇵🇱Wroclaw, Dolnośląskie, Poland
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Clinical Best Solutions
🇵🇱Lublin, Lubelskie, Poland
CenterMed Lublin NZOZ
🇵🇱Lublin, Lubelskie, Poland
Ekamed
🇵🇱Lublin, Lubelskie, Poland
Centrum Medyczne "Diabetika"
🇵🇱Radom, Mazowieckie, Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
🇵🇱Krakow, Małopolskie, Poland
Zdrowie Osteo-Medic
🇵🇱Bialystok, Podlaskie, Poland
Specderm Poznanska
🇵🇱Bialystok, Podlaskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Łódzkie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
🇵🇱Zabrze, Śląskie, Poland
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Fu Jen Catholic University Hospital
🇨🇳New Taipei, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan