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

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Study Assessing Time in Target Glucose Range Using a New Titration Scheme of LY900014 and Insulin Degludec in Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: LY900014
* Drug: Insulin Degludec


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY900014 + Insulin Degludec<br>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. | Drug: LY900014<br>* Administered SC<br>Drug: Insulin Degludec<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) | Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM. | Day 46 | 

Secondary Outcome Measures

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