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A Study of LY3209590 in Participants With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3209590
Insulin Degludec
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Muir Physician Network Clinical Research Center
  • Valley Endocrine, Fresno
  • Coastal Metabolic Research Centre
  • Barbara Davis Center for Childhood Diabetes
  • Denver Endocrinology, Diabetes & Thyroid Center
  • East Coast Institute for Research at The Jones Center
  • Sun Coast Clinical Research, Inc
  • Bayside Clinical Research, LLC
  • Metabolic Research Institute, Inc.
  • Atlanta Diabetes Associates
  • East Coast Institute for Research at The Jones Center
  • Endocrine Research Solutions, Inc.
  • Rocky Mountain Clinical Research
  • Iowa Diabetes and Endocrinology Research Center
  • Diabetes and Metabolism Associates, APMC
  • Endocrine and Metabolic Consultants
  • Palm Research Center Tenaya
  • Southern Nh Diabetes and Endocrinology
  • Suny Health Science Center at Syracuse
  • Lucas Research, Inc.
  • PMG Research of Piedmont Healthcare
  • PMG Research of Wilmington
  • Intend Research, LLC
  • Holston Medical Group
  • Univ Diab & Endo Consult
  • Texas Diabetes & Endocrinology, P.A.
  • Research Institute of Dallas
  • Diabetes and Thyroid Center of Fort Worth
  • Endocrine and Psychiatry Center
  • Southern Endocrinology Associates
  • Texas Diabetes & Endocrinology, P.A.
  • Consano Clinical Research, LLC
  • Rainier Clinical Research Center
  • Universitätsklinikum Graz
  • Klinik Landstraße
  • Zentrum für klinische Studien Dr Hanusch Gmbh
  • Praxis Dr. Jörg Lüdemann
  • InnoDiab Forschung Gmbh
  • Institut für Diabetesforschung GmbH Münster
  • Practice Dr.med. Denger and Dr.med. Pfitzner
  • Zentrum für klinische Studien
  • SMO.MD GmbH
  • RED-Institut GmbH
  • Diabeteszentrum Hamburg West
  • Dr Altagracia Aurora Alcantara Gonzalez
  • Advanced Clinical Research, LLC
  • Martha Gomez Cuellar M.D.
  • Hospital Universitario Virgen de la Victoria
  • Hospital Quiron Infanta Luisa
  • Hospital Universitario de La Ribera
  • Centro Periférico de Especialidades Bola Azul
  • Complexo Hospitalario Universitario A Coruña, CHUAC
  • Clínica nuevas Tecnologías en Diabetes y Endocrinología
  • Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LY3209590 Algorithm 1 (Paper)

LY3209590 Algorithm 2 (Digital)

Insulin Degludec

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 26, 2020
Last Updated
September 29, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04450407
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3209590 Algorithm 1 (Paper)
Arm Type
Experimental
Arm Description
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).
Arm Title
LY3209590 Algorithm 2 (Digital)
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin Degludec
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LY3209590
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Description
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.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Serum Glucose
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Bolus Insulin Dose
Description
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.
Time Frame
Baseline, Week 26
Title
Rate of Documented Hypoglycemia
Description
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.
Time Frame
Baseline through Week 26
Title
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
Description
AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value.
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
John Muir Physician Network Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Valley Endocrine, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Coastal Metabolic Research Centre
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Endocrinology, Diabetes & Thyroid Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
East Coast Institute for Research at The Jones Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Sun Coast Clinical Research, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Bayside Clinical Research, LLC
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
East Coast Institute for Research at The Jones Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Diabetes and Metabolism Associates, APMC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Palm Research Center Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Southern Nh Diabetes and Endocrinology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Suny Health Science Center at Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Piedmont Healthcare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Univ Diab & Endo Consult
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4309
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Diabetes and Thyroid Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Endocrine and Psychiatry Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Universitätsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinik Landstraße
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Facility Name
Zentrum für klinische Studien Dr Hanusch Gmbh
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Praxis Dr. Jörg Lüdemann
City
Falkensee
State/Province
Brandenburg
ZIP/Postal Code
14612
Country
Germany
Facility Name
InnoDiab Forschung Gmbh
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Institut für Diabetesforschung GmbH Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Practice Dr.med. Denger and Dr.med. Pfitzner
City
Friedrichsthal
State/Province
Saarland
ZIP/Postal Code
66299
Country
Germany
Facility Name
Zentrum für klinische Studien
City
Saint Ingbert
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
SMO.MD GmbH
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Diabeteszentrum Hamburg West
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Dr Altagracia Aurora Alcantara Gonzalez
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Advanced Clinical Research, LLC
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Martha Gomez Cuellar M.D.
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hospital Universitario de La Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Centro Periférico de Especialidades Bola Azul
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña, CHUAC
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Clínica nuevas Tecnologías en Diabetes y Endocrinología
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5dp7c1Y8s5tS3GBCoGr1YO
Description
A Study of LY3209590 in Participants With Type 1 Diabetes

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A Study of LY3209590 in Participants With Type 1 Diabetes

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