A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Degludec; Drug: LY900014; Drug: SGLT2 inhibitor; Drug: Insulin Glargine; Drug: Metformin; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03214380

I8B-MC-ITRN (Other Identifier)

16314

2015-005357-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

Enrollment: 933 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.

• Have been treated for at least 90 days prior to screening with:

  • Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
  • Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily

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

  • Metformin
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor
  • Sodium glucose cotransporter 2 (SGLT2) inhibitor
  • Sulfonylurea
  • Meglitinide
  • Alpha-glucoside inhibitor

• Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.

• Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

Exclusion criteria

• Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
• Have hypoglycemia unawareness as judged by the investigator.
• Have had any episode of severe hypoglycemia within the 6 months prior to screening.
• Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
• Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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933 participants in 4 patient groups

LY900014

Experimental group

Description:

LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Treatment:

Drug: Metformin

Drug: Insulin Degludec

Drug: SGLT2 inhibitor

Drug: LY900014

Drug: Insulin Glargine

Insulin Lispro (Humalog)

Active Comparator group

Description:

Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Treatment:

Drug: Metformin

Drug: Insulin Degludec

Drug: Insulin Lispro

Drug: SGLT2 inhibitor

Drug: Insulin Glargine

LY900014 Maximum Extended Enrollment (MEE)

Experimental group

Description:

LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Treatment:

Drug: Metformin

Drug: Insulin Degludec

Drug: SGLT2 inhibitor

Drug: LY900014

Drug: Insulin Glargine

Insulin Lispro (Humalog) MEE

Active Comparator group

Description:

Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Treatment:

Drug: Metformin

Drug: Insulin Degludec

Drug: Insulin Lispro

Drug: SGLT2 inhibitor

Drug: Insulin Glargine