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NCT04585776 Clinical Trial

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

Type 1 Diabetes Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04585776
Other study ID # 17601
Secondary ID I8B-MC-ITSZ
Status Completed
Phase Phase 2
First received
Last updated
Start date October 30, 2020
Est. completion date May 27, 2021

Study information
Verified date May 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date May 27, 2021
Est. primary completion date May 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• LY900014
Administered SC
• Insulin Degludec
Administered SC

Locations
Country Name City State
United States Atlanta Diabetes Associates Atlanta Georgia
United States HealthPartners Institute dba International Diabetes Center Minneapolis Minnesota
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Insulin to Carbohydrate Ratio (ICR) ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin. Day 46
Secondary Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin Prandial:TDD ratio Day 46
Secondary 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
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