A Study of LY3209590 in Participants With Type 1 Diabetes

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Degludec; Drug: LY3209590

Study type: Interventional

Funder types: Industry

Identifiers

NCT04450407

17183

2019-003589-41 (EudraCT Number)

I8H-MC-BDCP (Other Identifier)

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 3 patient groups

LY3209590 Algorithm 1 (Paper)

Experimental group

Description:

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 basal insulin dose prior randomization and baseline fasting glucose 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).

Treatment:

Drug: LY3209590

LY3209590 Algorithm 2 (Digital)

Experimental group

Description:

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 basal insulin dose prior randomization and baseline fasting glucose 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.

Treatment:

Drug: LY3209590

Insulin Degludec

Active Comparator group

Description:

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 same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.

Treatment:

Drug: Insulin Degludec