A Study of LY3209590 in Participants With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450407
• Other study ID #: 17183
• Secondary ID: I8H-MC-BDCP2019-
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• LY3209590
Administered SC
• Insulin Degludec
Administered SC

Locations

Country	Name	City	State
Austria	Universitätsklinikum Graz	Graz	Steiermark
Austria	Klinik Landstraße	Vienna
Austria	Zentrum für klinische Studien Dr Hanusch Gmbh	Wien
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	Praxis Dr. Jörg Lüdemann	Falkensee	Brandenburg
Germany	Practice Dr.med. Denger and Dr.med. Pfitzner	Friedrichsthal	Saarland
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	SMO.MD GmbH	Magdeburg	Sachsen-Anhalt
Germany	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-Westfalen
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Zentrum für klinische Studien	Saint Ingbert	Saarland
Puerto Rico	Advanced Clinical Research, LLC	Bayamon
Puerto Rico	Dr Altagracia Aurora Alcantara Gonzalez	Bayamon
Puerto Rico	Martha Gomez Cuellar M.D.	San Juan
Spain	Centro Periférico de Especialidades Bola Azul	Almeria
Spain	Hospital Universitario de La Ribera	Alzira	Valencia
Spain	Complexo Hospitalario Universitario A Coruña, CHUAC	La Coruña
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Andalucia
Spain	Clínica nuevas Tecnologías en Diabetes y Endocrinología	Sevilla
Spain	Hospital Quiron Infanta Luisa	Sevilla	Andalucia
Spain	Hospital Universitario Virgen Macarena	Sevilla
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Holston Medical Group	Bristol	Tennessee
United States	Univ Diab & Endo Consult	Chattanooga	Tennessee
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Research Institute of Dallas	Dallas	Texas
United States	Denver Endocrinology, Diabetes & Thyroid Center	Englewood	Colorado
United States	Diabetes and Thyroid Center of Fort Worth	Fort Worth	Texas
United States	Valley Endocrine, Fresno	Fresno	California
United States	Endocrine and Psychiatry Center	Houston	Texas
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	East Coast Institute for Research at The Jones Center	Jacksonville	Florida
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	East Coast Institute for Research at The Jones Center	Macon	Georgia
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Diabetes and Metabolism Associates, APMC	Metairie	Louisiana
United States	Lucas Research, Inc.	Morehead City	North Carolina
United States	Southern Nh Diabetes and Endocrinology	Nashua	New Hampshire
United States	Bayside Clinical Research, LLC	New Port Richey	Florida
United States	Sun Coast Clinical Research, Inc	New Port Richey	Florida
United States	Intend Research, LLC	Norman	Oklahoma
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	PMG Research of Piedmont Healthcare	Statesville	North Carolina
United States	Suny Health Science Center at Syracuse	Syracuse	New York
United States	Coastal Metabolic Research Centre	Ventura	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.	Baseline, Week 26
Secondary	Change From Baseline in Fasting Serum Glucose	LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate.	Baseline, Week 26
Secondary	Change From Baseline in Bolus Insulin Dose	Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate.	Baseline, Week 26
Secondary	Rate of Documented Hypoglycemia	Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose <54 mg/dL (3.0 millimole per liter (mmol/L)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants.	Baseline through Week 26
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590	AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value.	Week 26

External Links

•   A Study of LY3209590 in Participants With Type 1 Diabetes