Clinical trial NCT04450407: A Study of LY3209590 in Participants With Type 1 Diabetes
Official title: A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 266
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 reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
* Participants must have been using multiple daily injections without interruption for at least 3 months
* Participants must have HbA1c values of 5.6% to 9.5%, inclusive
* Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
* 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: Change From Baseline in Bolus Insulin Dose
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: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Fresno
country: United States
facility: Valley Endocrine, Fresno
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Centre
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Englewood
country: United States
facility: Denver Endocrinology, Diabetes & Thyroid Center
state: Colorado
city: Jacksonville
country: United States
facility: East Coast Institute for Research at The Jones Center
state: Florida
city: New Port Richey
country: United States
facility: Sun Coast Clinical Research, Inc
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research at The Jones Center
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Metairie
country: United States
facility: Diabetes and Metabolism Associates, APMC
state: Louisiana
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Nashua
country: United States
facility: Southern Nh Diabetes and Endocrinology
state: New Hampshire
city: Syracuse
country: United States
facility: Suny Health Science Center at Syracuse
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Statesville
country: United States
facility: PMG Research of Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Chattanooga
country: United States
facility: Univ Diab & Endo Consult
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Endocrine and Psychiatry Center
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
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: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Vienna
country: Austria
facility: Klinik Landstraße
city: Wien
country: Austria
facility: Zentrum für klinische Studien Dr Hanusch Gmbh
city: Falkensee
country: Germany
facility: Praxis Dr. Jörg Lüdemann
state: Brandenburg
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: Saint Ingbert
country: Germany
facility: Zentrum für klinische Studien
state: Saarland
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen-Anhalt
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Bayamon
country: Puerto Rico
facility: Dr Altagracia Aurora Alcantara Gonzalez
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: San Juan
country: Puerto Rico
facility: Martha Gomez Cuellar M.D.
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
state: Andalucia
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Valencia
city: Almeria
country: Spain
facility: Centro Periférico de Especialidades Bola Azul
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña, CHUAC
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
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: