- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450394
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, 1407
- CEMEDIC
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Buenos Aires, Argentina, C1419AHN
- Asociación de Beneficencia Hospital Sirio Libanés
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Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
- Instituto Centenario
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Cordoba, Argentina, X5008HHW
- Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
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Tucuman, Argentina, T4000IHE
- Clínica Mayo
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1120AAC
- Centro Médico Viamonte
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Caba, Buenos Aires, Argentina, C1179AAB
- Investigaciones Medicas Imoba Srl
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Caba, Buenos Aires, Argentina, C1180AAX
- Fundacion Sanatorio Güemes
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Caba, Buenos Aires, Argentina, C1405BUB
- Consultorio de Investigación Clínica EMO SRL
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Caba, Buenos Aires, Argentina, C1425DES
- CEDIC
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- Instituto Medico Catamarca
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Hamburg, Germany, 22607
- Diabeteszentrum Hamburg West
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Nordrhein-Westfalen
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Bochum, Nordrhein-Westfalen, Germany, 44869
- Diabetes- und Stoffwechselpraxis Bochum
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Essen, Nordrhein-Westfalen, Germany, 45136
- InnoDiab Forschung GmbH
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Münster, Nordrhein-Westfalen, Germany, 48145
- Institut für Diabetesforschung GmbH Münster
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Saarland
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Friedrichsthal, Saarland, Germany, 66299
- Practice Dr.med. Denger and Dr.med. Pfitzner
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Sachsen
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Pirna, Sachsen, Germany, 01796
- Private Practice - Dr. Christine Kosch
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Germany, 39120
- SMO.MD GmbH
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Schleswig-Holstein
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Oldenburg, Schleswig-Holstein, Germany, 23758
- RED-Institut GmbH
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Elblag, Poland, 82-300
- Centrum Kliniczno-Badawcze
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Lodz, Poland, 90242
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
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Lublin, Poland, 20-333
- Gabinety TERPA
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Poznan, Poland, 61-655
- Praktyka Lekarska
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Poznan, Poland, 60-111
- OMEDICA Medical Center
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Wierzchosławice, Poland, 33-122
- Poradnia Chorob Metabolicznych
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Wroclaw, Poland, 50-127
- NZOZ Regionalna Poradnia Diabetologiczna
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Masovian
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Warsaw, Masovian, Poland, 02-117
- Instytut Diabetologii Sp. z o.o
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Małopolskie
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Krakow, Małopolskie, Poland, 31-261
- Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
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Pomorskie
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Gdansk, Pomorskie, Poland, 80-546
- Centrum Badan Klinicznych PI-House Sp. z o.o.
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Slaskie
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Ruda Slaska, Slaskie, Poland, 41-709
- NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
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Ponce, Puerto Rico, 00717
- Research and Cardiovascular Corp.
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San Juan, Puerto Rico, 00917
- GCM Medical Group, PSC - Hato Rey Site
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Yabucoa, Puerto Rico, 00767
- Centro Profesional de Endocrinologia del Este
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Alabama
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Sheffield, Alabama, United States, 35660
- Syed Research Consultants Llc
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California
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Huntington Park, California, United States, 90255
- National Research Institute - Huntington Park
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Los Angeles, California, United States, 90057
- National Research Institute - Wilshire
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Montclair, California, United States, 91763
- Catalina Research Institute, LLC
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Spring Valley, California, United States, 91978
- Encompass Clinical Research
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Connecticut
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Waterbury, Connecticut, United States, 06708
- CMR of Greater New Haven
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Florida
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Cooper City, Florida, United States, 33024
- ALL Medical Research, LLC
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Fort Lauderdale, Florida, United States, 33312
- Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
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Miami, Florida, United States, 33135
- Suncoast Research Group
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Miami, Florida, United States, 33165 3338
- New Horizon Research Center
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New Port Richey, Florida, United States, 34652
- Suncoast Clinical Research
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Georgia
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Union City, Georgia, United States, 30291
- Rophe Adult and Pediatric Medicine
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Idaho
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Blackfoot, Idaho, United States, 83221
- Elite Clinical Trials
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Clinical Research
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Rexburg, Idaho, United States, 83440
- Elite Clinical Trials
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Iowa
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West Des Moines, Iowa, United States, 50265
- Iowa Diabetes and Endocrinology Research Center
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Kansas
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Diabetes and Endocrinology Center
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Kentucky
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Louisville, Kentucky, United States, 40213
- L-MARC Research Center
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Maryland
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Rockville, Maryland, United States, 20852
- Endocrine and Metabolic Consultants
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Mississippi
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Ridgeland, Mississippi, United States, 39157
- Sky Clin Resch - Quinn HC
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North Dakota
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Fargo, North Dakota, United States, 58104
- Lillestol Research LLC
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Intend Research, LLC
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Pennsylvania
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Uniontown, Pennsylvania, United States, 15401
- Preferred Primary Care Physicians
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Tennessee
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Bristol, Tennessee, United States, 37620
- Holston Medical Group
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Texas
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Austin, Texas, United States, 78731-4309
- Texas Diabetes & Endocrinology, P.A.
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Dallas, Texas, United States, 75230
- Dallas Diabetes Research Center
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Houston, Texas, United States, 77040
- Juno Research
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Houston, Texas, United States, 77074
- Juno Research - Gessner
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Mesquite, Texas, United States, 75149
- Southern Endocrinology Associates
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Shavano Park, Texas, United States, 78231
- Consano Clinical Research, LLC
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Washington
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Renton, Washington, United States, 98057
- Rainier Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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 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).
|
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 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. |
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 of 10 units, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.
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Administered SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 26
|
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.
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Baseline, Week 26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 26
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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.
|
Baseline, Week 26
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Rate of Documented Hypoglycemia
Time Frame: Baseline through Week 26
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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.
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Baseline through Week 26
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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
Time Frame: Week 26
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AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.
|
Week 26
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17056
- I8H-MC-BDCL (Other Identifier: Eli Lilly and Company)
- 2019-003339-53 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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