A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736785
• Other study ID #: 17059
• Secondary ID: I8H-MC-BDCM
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2018
• Est. completion date: February 18, 2020

Study information

• Verified date: March 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LY3209590
Administered SC
• Insulin Degludec
Administered SC

Locations

Country	Name	City	State
Mexico	Investigacion en Salud y Metabolismo S.C	Chihuahua
Mexico	Hospital Universitario UANL	Monterrey	Nuevo León
Puerto Rico	Advanced Clinical Research, LLC	Bayamon
Puerto Rico	Manati Center for Clinical Research Inc	Manati
Puerto Rico	GCM Medical Group PSC	San Juan
Puerto Rico	Martha Gomez Cuellar M.D.	San Juan
Puerto Rico	Centro de Endocrinologia del Este	Yabucoa
United States	Internal Medicine Associates of Anderson	Anderson	South Carolina
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	Elite Clinical Trials LLLP	Blackfoot	Idaho
United States	Metrolina Internal Medicine, P.A.	Charlotte	North Carolina
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	ALL Medical Research, LLC	Cooper City	Florida
United States	The Corvallis Clinic P.C.	Corvallis	Oregon
United States	Dallas Diabetes Endocrine Center	Dallas	Texas
United States	AMCR Institute INC	Escondido	California
United States	NECCR PrimaCare Research, LLC	Fall River	Massachusetts
United States	Valley Endocrine, Fresno	Fresno	California
United States	Marin Endocrine Associates	Greenbrae	California
United States	East West Medical Institute	Honolulu	Hawaii
United States	National Research Institute	Huntington Park	California
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho
United States	First Valley Medical Group	Lancaster	California
United States	Palm Research Center	Las Vegas	Nevada
United States	Palm Research Center	Las Vegas	Nevada
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	National Research Institute	Los Angeles	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	The Research Center of the Upstate	Mauldin	South Carolina
United States	Southern New Hampshire Diabetes and Endocrinology	Nashua	New Hampshire
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Intend Research	Norman	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Cotton O'Neil Diabetes and Endocrinology Center	Topeka	Kansas
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Preferred Primary Care Physicians - Jacob Murphy Lane	Uniontown	Pennsylvania
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Confluence Health Clinical Research Department	Wenatchee	Washington
United States	Iderc, P.L.C.	West Des Moines	Iowa
United States	Metabolic Research Institute Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c	HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.; Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or = 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.	Baseline, Week 32
Secondary	Change From Baseline in HbA1c Compared to Insulin Degludec	HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.; Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or = 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate.	Baseline, Week 32
Secondary	Change From Baseline in Fasting Glucose	Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or = 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or =8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate.	Baseline, Week 32
Secondary	Change From Baseline in Insulin Dose (LY3209590)	The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.	Week 1, Week 32
Secondary	Change From Baseline in Insulin Dose (Insulin Degludec)	Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.	Baseline, Week 32
Secondary	Rate of Total Documented Symptomatic Hypoglycemia	The hypoglycemia events were defined by participant reported events with glucose =54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants.	Baseline through week 32
Secondary	Change From Baseline in Body Weight	Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate.	Baseline, Week 32
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590	PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value.	Week 32

External Links

•   A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus