A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: LY900014; Drug: Insulin Degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT04585776

17601

I8B-MC-ITSZ (Other Identifier)

Details and patient eligibility

About

In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
• Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
• Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
• Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening

Exclusion criteria

• Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
• Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
• Participants must not be taking certain diabetes medications that are not allowed for study participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

LY900014 + Insulin Degludec

Experimental group

Description:

LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.

Treatment:

Drug: Insulin Degludec

Drug: LY900014