A Study of LY3209590 in Participants With Type 1 Diabetes
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04450407
Collaborator
(none)
266
54
2
14.9
4.9
0.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
266 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jul 6, 2020
Actual Primary Completion Date
:
Oct 1, 2021
Actual Study Completion Date
:
Oct 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3209590 Algorithm 1 LY3209590 administered subcutaneously (SC). |
Drug: LY3209590
Administered SC
|
| Active Comparator: Insulin Degludec Insulin degludec administered SC. |
Drug: Insulin Degludec
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 26]
Change from Baseline in HbA1c
Secondary Outcome Measures
- Change from Baseline in Fasting Glucose [Baseline, Week 26]
Change from Baseline in Fasting Glucose
- Change from Baseline in Bolus Insulin Dose [Baseline, Week 26]
Change from Baseline in Bolus Insulin Dose
- Rate of Documented Hypoglycemia [Baseline through Week 26]
Rate of Documented Hypoglycemia
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 [Baseline through Week 26]
PK: AUC of LY3209590
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | John Muir Physician Network Clinical Research Center | Concord | California | United States | 94520 |
| 2 | Valley Endocrine, Fresno | Fresno | California | United States | 93720 |
| 3 | Coastal Metabolic Research Centre | Ventura | California | United States | 93003 |
| 4 | Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | United States | 80045 |
| 5 | Denver Endocrinology, Diabetes & Thyroid Center | Englewood | Colorado | United States | 80113 |
| 6 | East Coast Institute for Research at The Jones Center | Jacksonville | Florida | United States | 32204 |
| 7 | Sun Coast Clinical Research, Inc | New Port Richey | Florida | United States | 34652 |
| 8 | Bayside Clinical Research, LLC | New Port Richey | Florida | United States | 34655 |
| 9 | Metabolic Research Institute, Inc. | West Palm Beach | Florida | United States | 33401 |
| 10 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30318 |
| 11 | East Coast Institute for Research at The Jones Center | Macon | Georgia | United States | 31210 |
| 12 | Endocrine Research Solutions, Inc. | Roswell | Georgia | United States | 30076 |
| 13 | Rocky Mountain Clinical Research | Idaho Falls | Idaho | United States | 83404 |
| 14 | Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | United States | 50265 |
| 15 | Diabetes and Metabolism Associates, APMC | Metairie | Louisiana | United States | 70006 |
| 16 | Endocrine and Metabolic Consultants | Rockville | Maryland | United States | 20852 |
| 17 | Palm Research Center Tenaya | Las Vegas | Nevada | United States | 89128 |
| 18 | Southern Nh Diabetes and Endocrinology | Nashua | New Hampshire | United States | 03060 |
| 19 | Suny Health Science Center at Syracuse | Syracuse | New York | United States | 13210 |
| 20 | Lucas Research, Inc. | Morehead City | North Carolina | United States | 28557 |
| 21 | PMG Research of Piedmont Healthcare | Statesville | North Carolina | United States | 28625 |
| 22 | PMG Research of Wilmington | Wilmington | North Carolina | United States | 28401 |
| 23 | Intend Research, LLC | Norman | Oklahoma | United States | 73069 |
| 24 | Holston Medical Group | Bristol | Tennessee | United States | 37620 |
| 25 | Univ Diab & Endo Consult | Chattanooga | Tennessee | United States | 37411 |
| 26 | Texas Diabetes & Endocrinology, P.A. | Austin | Texas | United States | 78731-4309 |
| 27 | Research Institute of Dallas | Dallas | Texas | United States | 75231 |
| 28 | Diabetes and Thyroid Center of Fort Worth | Fort Worth | Texas | United States | 76132 |
| 29 | Endocrine and Psychiatry Center | Houston | Texas | United States | 77095 |
| 30 | Southern Endocrinology Associates | Mesquite | Texas | United States | 75149 |
| 31 | Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas | United States | 78681 |
| 32 | Consano Clinical Research, LLC | Shavano Park | Texas | United States | 78231 |
| 33 | Rainier Clinical Research Center | Renton | Washington | United States | 98057 |
| 34 | Universitätsklinikum Graz | Graz | Steiermark | Austria | 8036 |
| 35 | Klinik Landstraße | Vienna | Austria | 1030 | |
| 36 | Zentrum für klinische Studien Dr Hanusch Gmbh | Wien | Austria | 1060 | |
| 37 | Praxis Dr. Jörg Lüdemann | Falkensee | Brandenburg | Germany | 14612 |
| 38 | InnoDiab Forschung Gmbh | Essen | Nordrhein-Westfalen | Germany | 45136 |
| 39 | Institut für Diabetesforschung GmbH Münster | Münster | Nordrhein-Westfalen | Germany | 48145 |
| 40 | Practice Dr.med. Denger and Dr.med. Pfitzner | Friedrichsthal | Saarland | Germany | 66299 |
| 41 | Zentrum für klinische Studien | Saint Ingbert | Saarland | Germany | 66386 |
| 42 | SMO.MD GmbH | Magdeburg | Sachsen-Anhalt | Germany | 39120 |
| 43 | RED-Institut GmbH | Oldenburg | Schleswig-Holstein | Germany | 23758 |
| 44 | Diabeteszentrum Hamburg West | Hamburg | Germany | 22607 | |
| 45 | Dr Altagracia Aurora Alcantara Gonzalez | Bayamon | Puerto Rico | 00956 | |
| 46 | Advanced Clinical Research, LLC | Bayamon | Puerto Rico | 00961 | |
| 47 | Martha Gomez Cuellar M.D. | San Juan | Puerto Rico | 00921 | |
| 48 | Hospital Universitario Virgen de la Victoria | Malaga | Andalucia | Spain | 29010 |
| 49 | Hospital Quiron Infanta Luisa | Sevilla | Andalucia | Spain | 41010 |
| 50 | Hospital Universitario de La Ribera | Alzira | Valencia | Spain | 46600 |
| 51 | Centro Periférico de Especialidades Bola Azul | Almeria | Spain | 04009 | |
| 52 | Complexo Hospitalario Universitario A Coruña, CHUAC | La Coruña | Spain | 15006 | |
| 53 | Clínica nuevas Tecnologías en Diabetes y Endocrinología | Sevilla | Spain | 41003 | |
| 54 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41007 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04450407
Other Study ID Numbers:
- 17183
- I8H-MC-BDCP
- 2019-003589-41
First Posted:
Jun 29, 2020
Last Update Posted:
Nov 2, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: