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

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: LY900014; Drug: Insulin Degludec

• Registration Number: NCT04585776
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Study Start: 2020-10-30
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Status Verified: 2022-05
• Results First Submitted: 2022-05-06
• Results First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Results First Posted: 2022-06-03
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY900014 + Insulin Degludec	LY900014	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.
LY900014 + Insulin Degludec	Insulin Degludec	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)	Day 46	Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.

Secondary Outcome Measures

Name	Time	Method
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin	Day 46	Prandial:TDD ratio
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)	Day 46	ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Insulin to Carbohydrate Ratio (ICR)	Day 46	ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.

Trial Locations

Locations (3)

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

HealthPartners Institute dba International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States