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
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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

External Links

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