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

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: LY3209590
Drug: Insulin Degludec

Registration Number: NCT04450394

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 278

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3209590 Algorithm 1 (Paper)	LY3209590	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).
LY3209590 Algorithm 2 (Digital)	LY3209590	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	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Serum Glucose	Baseline, Week 26	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.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590	Week 26	AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.
Rate of Documented Hypoglycemia	Baseline through Week 26	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.

Trial Locations

Locations (63): Syed Research Consultants Llc
🇺🇸
Sheffield, Alabama, United States
National Research Institute - Huntington Park
🇺🇸
Huntington Park, California, United States
National Research Institute - Wilshire
🇺🇸
Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸
Montclair, California, United States
Encompass Clinical Research
🇺🇸
Spring Valley, California, United States
CMR of Greater New Haven
🇺🇸
Waterbury, Connecticut, United States
ALL Medical Research, LLC
🇺🇸
Cooper City, Florida, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
🇺🇸
Fort Lauderdale, Florida, United States
Suncoast Research Group
🇺🇸
Miami, Florida, United States
New Horizon Research Center
🇺🇸
Miami, Florida, United States
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Syed Research Consultants Llc
🇺🇸Sheffield, Alabama, United States