A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: LY900014; Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04605991

17428 (Other Identifier)

I8B-MC-ITSW (Other Identifier)

Details and patient eligibility

About

This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.

• Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:

  • Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
  • Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.

• Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:

  1. Metformin
  2. Dipeptidyl peptidase-4 (DPP-4) inhibitor
  3. sodium glucose cotransporter 2 (SGLT2) inhibitor
  4. oral glucagon-like peptide 1 (GLP-1) agonist

• Doses of OAMs are required to have been stable for at least 90 days prior to screening.

• Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.

• Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.

Exclusion criteria

• Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
• Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
• Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
• Have hypoglycemia unawareness as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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187 participants in 1 patient group

LY900014

Experimental group

Description:

LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study.

Treatment:

Drug: Insulin Glargine

Drug: LY900014