Clinical trial NCT03736785: A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Official title: A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 that have already been treated with basal insulin.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):

  * dipeptidyl peptidase-4 (DPP-4) inhibitors
  * sodium-glucose cotransporter (SGLT-2) inhibitors
  * biguanides
  * alpha-glucosidase inhibitors
  * sulfonlyureas
* HbA1c value of 6.5% to 10%, inclusive
* Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Exclusion Criteria:

* Type 1 diabetes mellitus or latent autoimmune diabetes
* Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m2
* Active or untreated malignancy
* Chronic (\>14 days) systemic glucocorticoid therapy

Primary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: Baseline, Week 32
Secondary outcomes:
measure: Change From Baseline in HbA1c Compared to Insulin Degludec
timeFrame: Baseline, Week 32
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, Week 32
measure: Change From Baseline in Insulin Dose (LY3209590)
timeFrame: Week 1, Week 32
measure: Change From Baseline in Insulin Dose (Insulin Degludec)
timeFrame: Baseline, Week 32
measure: Rate of Total Documented Symptomatic Hypoglycemia
timeFrame: Baseline through week 32
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 32
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
timeFrame: Week 32
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Clinical Research
state: Arkansas
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Escondido
country: United States
facility: AMCR Institute INC
state: California
city: Fresno
country: United States
facility: Valley Endocrine, Fresno
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Associates
state: California
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc.
state: Florida
city: Honolulu
country: United States
facility: East West Medical Institute
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials LLLP
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: West Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research, LLC
state: Massachusetts
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: Charlotte
country: United States
facility: Metrolina Internal Medicine, P.A.
state: North Carolina
city: Norman
country: United States
facility: Intend Research
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic P.C.
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians - Jacob Murphy Lane
state: Pennsylvania
city: Anderson
country: United States
facility: Internal Medicine Associates of Anderson
state: South Carolina
city: Mauldin
country: United States
facility: The Research Center of the Upstate
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Wenatchee
country: United States
facility: Confluence Health Clinical Research Department
state: Washington
city: Monterrey
country: Mexico
facility: Hospital Universitario UANL
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigacion en Salud y Metabolismo S.C
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research Inc
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: San Juan
country: Puerto Rico
facility: Martha Gomez Cuellar M.D.
city: Yabucoa
country: Puerto Rico
facility: Centro de Endocrinologia del Este
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: