Clinical trial NCT04450394: A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Official title: A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
* Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
* Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

* Have type 1 diabetes mellitus or latent autoimmune diabetes
* Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
* Have active or untreated cancer
* Are receiving chronic (\>14 days) systemic glucocorticoid therapy

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 26
measure: Rate of Documented Hypoglycemia
timeFrame: Baseline through Week 26
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
timeFrame: Week 26
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Syed Research Consultants Llc
state: Alabama
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Waterbury
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Rexburg
country: United States
facility: Elite Clinical Trials
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Ridgeland
country: United States
facility: Sky Clin Resch - Quinn HC
state: Mississippi
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Juno Research - Gessner
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: Centro Médico Viamonte
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Buenos Aires
city: Caba
country: Argentina
facility: Fundacion Sanatorio Guemes
state: Buenos Aires
city: Caba
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Aires
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto Centenario
city: Cordoba
country: Argentina
facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
city: Tucuman
country: Argentina
facility: Clínica Mayo
city: Bochum
country: Germany
facility: Diabetes- und Stoffwechselpraxis Bochum
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Friedrichsthal
country: Germany
facility: Practice Dr.med. Denger and Dr.med. Pfitzner
state: Saarland
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen-Anhalt
city: Pirna
country: Germany
facility: Private Practice - Dr. Christine Kosch
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Warsaw
country: Poland
facility: Instytut Diabetologii Sp. z o.o
state: Masovian
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
state: Małopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Ruda Slaska
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
state: Slaskie
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
city: Lublin
country: Poland
facility: Gabinety TERPA
city: Poznan
country: Poland
facility: OMEDICA Medical Center
city: Poznan
country: Poland
facility: Praktyka Lekarska
city: Wierzchosławice
country: Poland
facility: Poradnia Chorob Metabolicznych
city: Wroclaw
country: Poland
facility: NZOZ Regionalna Poradnia Diabetologiczna
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: Yabucoa
country: Puerto Rico
facility: Centro Profesional de Endocrinologia del Este
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 - 5hours, EST)
role: STUDY_DIRECTOR
References: