A Study of LY3209590 in Participants With Type 1 Diabetes

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: LY3209590; Drug: Insulin Degludec

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1030
    • Klinik Landstraße
  • Wien, Austria, 1060
    • Zentrum für klinische Studien Dr Hanusch Gmbh
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinikum Graz
• Germany
  • Hamburg, Germany, 22607
    • Diabeteszentrum Hamburg West
  • Brandenburg
    • Falkensee, Brandenburg, Germany, 14612
      • Praxis Dr. Jörg Lüdemann
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • InnoDiab Forschung GmbH
    • Münster, Nordrhein-Westfalen, Germany, 48145
      • Institut für Diabetesforschung GmbH Münster
  • Saarland
    • Friedrichsthal, Saarland, Germany, 66299
      • Practice Dr.med. Denger and Dr.med. Pfitzner
    • Saint Ingbert, Saarland, Germany, 66386
      • Zentrum für klinische Studien
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • SMO.MD GmbH
  • Schleswig-Holstein
    • Oldenburg, Schleswig-Holstein, Germany, 23758
      • RED-Institut GmbH
• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Advanced Clinical Research, LLC
  • Bayamon, Puerto Rico, 00956
    • Dr Altagracia Aurora Alcantara Gonzalez
  • San Juan, Puerto Rico, 00921
    • Martha Gomez Cuellar M.D.
• Spain
  • Almeria, Spain, 04009
    • Centro Periferico De Especialidades Bola Azul
  • La Coruña, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña, CHUAC
  • Sevilla, Spain, 41007
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41003
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Andalucia
    • Malaga, Andalucia, Spain, 29010
      • Hospital Universitario Virgen de la Victoria
    • Sevilla, Andalucia, Spain, 41010
      • Hospital Quiron Infanta Luisa
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Hospital Universitario de La Ribera
• United States
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Clinical Research Center
    • Fresno, California, United States, 93720
      • Valley Endocrine, Fresno
    • Ventura, California, United States, 93003
      • Coastal Metabolic Research Centre
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes
    • Englewood, Colorado, United States, 80113
      • Denver Endocrinology, Diabetes & Thyroid Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research at The Jones Center
    • New Port Richey, Florida, United States, 34652
      • Sun Coast Clinical Research, Inc
    • New Port Richey, Florida, United States, 34655
      • Bayside Clinical Research, LLC
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research at The Jones Center
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions, Inc.
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Diabetes and Metabolism Associates, APMC
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Tenaya
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Southern NH Diabetes and Endocrinology
  • New York
    • Syracuse, New York, United States, 13210
      • Suny Health Science Center at Syracuse
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc.
    • Statesville, North Carolina, United States, 28625
      • PMG Research of Piedmont Healthcare
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group
    • Chattanooga, Tennessee, United States, 37411
      • Univ Diab & Endo Consult
  • Texas
    • Austin, Texas, United States, 78731-4309
      • Texas Diabetes & Endocrinology, P.A.
    • Dallas, Texas, United States, 75231
      • Research Institute of Dallas
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Center of Fort Worth
    • Houston, Texas, United States, 77095
      • Endocrine and Psychiatry Center
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3209590 Algorithm 1 (Paper); Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 milligrams per deciliter (mg/dL).	Drug: LY3209590; Administered SC
Experimental: LY3209590 Algorithm 2 (Digital); Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL. As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry.	Drug: LY3209590; Administered SC
Active Comparator: Insulin Degludec; Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.	Drug: Insulin Degludec; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3209590 in Participants With Type 1 Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 17183; I8H-MC-BDCP (Other Identifier: Eli Lilly and Company); 2019-003589-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No