Back to resultsA Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3209590
Insulin Degludec
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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
Sites / Locations
- Syed Research Consultants Llc
- National Research Institute - Huntington Park
- National Research Institute - Wilshire
- Catalina Research Institute, LLC
- Encompass Clinical Research
- CMR of Greater New Haven
- ALL Medical Research, LLC
- Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
- Suncoast Research Group
- New Horizon Research Center
- Suncoast Clinical Research
- Rophe Adult and Pediatric Medicine
- Elite Clinical Trials
- Rocky Mountain Clinical Research
- Elite Clinical Trials
- Iowa Diabetes and Endocrinology Research Center
- Cotton O'Neil Diabetes and Endocrinology Center
- L-MARC Research Center
- Endocrine and Metabolic Consultants
- Sky Clin Resch - Quinn HC
- Lillestol Research LLC
- Intend Research, LLC
- Preferred Primary Care Physicians
- Holston Medical Group
- Texas Diabetes & Endocrinology, P.A.
- Dallas Diabetes Research Center
- Juno Research
- Juno Research - Gessner
- Southern Endocrinology Associates
- Consano Clinical Research, LLC
- Rainier Clinical Research Center
- Centro Médico Viamonte
- Investigaciones Medicas Imoba Srl
- Fundacion Sanatorio Guemes
- Consultorio de Investigación Clínica EMO SRL
- CEDIC
- Instituto Médico Catamarca
- CEMEDIC
- Asociación de Beneficencia Hospital Sirio Libanés
- Instituto Centenario
- Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
- Clínica Mayo
- Diabetes- und Stoffwechselpraxis Bochum
- InnoDiab Forschung Gmbh
- Institut für Diabetesforschung GmbH Münster
- Practice Dr.med. Denger and Dr.med. Pfitzner
- SMO.MD GmbH
- Private Practice - Dr. Christine Kosch
- RED-Institut GmbH
- Diabeteszentrum Hamburg West
- Instytut Diabetologii Sp. z o.o
- Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
- Centrum Badan Klinicznych PI-House sp. z o.o.
- NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
- Centrum Kliniczno-Badawcze
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
- Gabinety TERPA
- OMEDICA Medical Center
- Praktyka Lekarska
- Poradnia Chorob Metabolicznych
- NZOZ Regionalna Poradnia Diabetologiczna
- Research and Cardiovascular Corp.
- GCM Medical Group, PSC - Hato Rey Site
- Centro Profesional de Endocrinologia del Este
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 baseline median fasting glucose and body weight 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 baseline median fasting glucose and body weight 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 of 10 units, 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, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) [<30, >=30]), 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 MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI [<30, >=30]), visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose 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)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period*365.25 days.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04450394
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 8, 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 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (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 baseline median fasting glucose and body weight 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 baseline median fasting glucose and body weight 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 of 10 units, 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, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) [<30, >=30]), 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 MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI [<30, >=30]), visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose 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)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period*365.25 days.
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 participants' Week 26 LY3209590 dose amount and estimated clearance value.
Time Frame
Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
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
Syed Research Consultants Llc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
CMR of Greater New Haven
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
ALL Medical Research, LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165 3338
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Rophe Adult and Pediatric Medicine
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Elite Clinical Trials
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
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
Cotton O'Neil Diabetes and Endocrinology Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Sky Clin Resch - Quinn HC
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
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
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Juno Research - Gessner
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
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
Centro Médico Viamonte
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Investigaciones Medicas Imoba Srl
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Fundacion Sanatorio Guemes
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Consultorio de Investigación Clínica EMO SRL
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1405BUB
Country
Argentina
Facility Name
CEDIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
Facility Name
Instituto Médico Catamarca
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
CEMEDIC
City
Buenos Aires
ZIP/Postal Code
1407
Country
Argentina
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Instituto Centenario
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1204AAD
Country
Argentina
Facility Name
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
Clínica Mayo
City
Tucuman
ZIP/Postal Code
T4000IHE
Country
Argentina
Facility Name
Diabetes- und Stoffwechselpraxis Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44869
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
SMO.MD GmbH
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Private Practice - Dr. Christine Kosch
City
Pirna
State/Province
Sachsen
ZIP/Postal Code
01796
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
Instytut Diabetologii Sp. z o.o
City
Warsaw
State/Province
Masovian
ZIP/Postal Code
02-117
Country
Poland
Facility Name
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
31-261
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
City
Ruda Slaska
State/Province
Slaskie
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Centrum Kliniczno-Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90242
Country
Poland
Facility Name
Gabinety TERPA
City
Lublin
ZIP/Postal Code
20-333
Country
Poland
Facility Name
OMEDICA Medical Center
City
Poznan
ZIP/Postal Code
60-111
Country
Poland
Facility Name
Praktyka Lekarska
City
Poznan
ZIP/Postal Code
61-655
Country
Poland
Facility Name
Poradnia Chorob Metabolicznych
City
Wierzchosławice
ZIP/Postal Code
33-122
Country
Poland
Facility Name
NZOZ Regionalna Poradnia Diabetologiczna
City
Wroclaw
ZIP/Postal Code
50-127
Country
Poland
Facility Name
Research and Cardiovascular Corp.
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Centro Profesional de Endocrinologia del Este
City
Yabucoa
ZIP/Postal Code
00767
Country
Puerto Rico
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/6qyhRt87M4hnov8DyzZZhb
Description
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Learn more about this trial
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
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