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

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Degludec; Drug: LY3209590

Study type: Interventional

Funder types: Industry

Identifiers

NCT04450394

I8H-MC-BDCL (Other Identifier)

2019-003339-53 (EudraCT Number)

17056

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 2 diabetes.

Enrollment: 278 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 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 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).

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 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.

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 of 10 units, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.

Treatment:

Drug: Insulin Degludec