Clinical trial NCT06192108: A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin
Official title: A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 888
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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c: (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Change from Baseline in HbA1c
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))
timeFrame: Week 40
measure: Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
timeFrame: Week 40
measure: Percentage Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Triglycerides
timeFrame: Baseline, Week 40
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 40
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline
timeFrame: Baseline to Week 40
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 40
measure: Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores
timeFrame: Baseline, Week 40
measure: Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores
timeFrame: Baseline, Week 40
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Alliance Research Institute - Canoga Park
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Tustin
country: United States
facility: Wolverine Clinical Trials
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Stockbridge
country: United States
facility: Institute of Endocrinology Diabetes, Health & Hormone
state: Georgia
city: Rexburg
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Lombard
country: United States
facility: Accellacare - DuPage
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Billings
country: United States
facility: St. Vincent Healthcare
state: Montana
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem
state: North Carolina
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Mount Pleasant
country: United States
facility: Accellacare - Mt Pleasant
state: South Carolina
city: Jefferson City
country: United States
facility: Accellacare, US Inc., d/b/a Accellacare of Knoxville
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim
state: Baden-Württemberg
city: Lingen
country: Germany
facility: Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
state: Niedersachsen
city: Bochum
country: Germany
facility: Diabetes- und Stoffwechselpraxis Bochum
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Zentrum fur klinische Forschung - Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Rehlingen
country: Germany
facility: Praxis Dr. Veronika Wenzl-Bauer
state: Saarland
city: Saint Ingbert
country: Germany
facility: Zentrum für klinische Studien
state: Saarland
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wilhelmsburg
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: ProcliniQ Investigación Clínica SA de CV
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Grupo Ollin Care
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes, Obesidad y Nutricion
state: Morelos
city: Hacienda De Las Palmas
country: Mexico
facility: Invecordis S.C.
state: México
city: Monterrey
country: Mexico
facility: Cardiolink Clin Trials
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: San Nicolas de los Garza
country: Mexico
facility: Servicios Integrales Nova de Monterrey S.A. de C.V.
state: Nuevo León
city: Culiacan
country: Mexico
facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Xalapa
country: Mexico
facility: Consultorio de Medicina Especilizada del Sector Privado
state: Veracruz
city: Xalapa
country: Mexico
facility: Hospital Angeles Xalapa
state: Veracruz
city: Aguascalientes
country: Mexico
facility: Fundación Cardiovascular de Aguascalientes A.C.
city: Durango
country: Mexico
facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
city: Wroclaw
country: Poland
facility: Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Clinical Best Solutions
state: Lubelskie
city: Lublin
country: Poland
facility: CenterMed Lublin NZOZ
state: Lubelskie
city: Lublin
country: Poland
facility: Ekamed
state: Lubelskie
city: Radom
country: Poland
facility: Centrum Medyczne "Diabetika"
state: Mazowieckie
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
state: Małopolskie
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic
state: Podlaskie
city: Bialystok
country: Poland
facility: Specderm Poznanska
state: Podlaskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
state: Śląskie
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei
country: Taiwan
facility: Fu Jen Catholic University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
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: