A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: LY3209590; Drug: Insulin Degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT03736785

17059

I8H-MC-BDCM (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 2 diabetes that have already been treated with basal insulin.

Enrollment: 399 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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399 participants in 3 patient groups

LY3209590 Algorithm 1

Experimental group

Description:

Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of \<140 milligram per deciliter (mg/dL).

Treatment:

Drug: LY3209590

LY3209590 Algorithm 2

Experimental group

Description:

Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of \<120 mg/dL.

Treatment:

Drug: LY3209590

Insulin Degludec

Active Comparator group

Description:

Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C \<7%.

Treatment:

Drug: Insulin Degludec