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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2021-05-27

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.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY900014 + 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.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Insulin Degludec

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered SC

Intervention Type DRUG

Insulin Degludec

Administered SC

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No