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

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

Sponsors

Lead Sponsor: Eli Lilly and Company

Source 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.

Overall Status Not yet recruiting
Start Date October 16, 2020
Completion Date March 29, 2021
Primary Completion Date March 29, 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Time with Sensor Glucose Values Between 70 and 180 milligrams per deciliter (mg/dL) with Continuous Glucose Monitoring (CGM) Day 36 to Day 45
Secondary Outcome
Measure Time Frame
Insulin to Carbohydrate Ratio (ICR) Day 45
Prandial: Total Daily Dose (TDD) Ratio Day 36 to Day 45
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: LY900014

Description: Administered SC

Arm Group Label: LY900014 + Insulin Degludec

Intervention Type: Drug

Intervention Name: Insulin Degludec

Description: Administered SC

Arm Group Label: LY900014 + Insulin Degludec

Eligibility

Criteria:

Inclusion Criteria:

- Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year

- Participants must be using Dexcom G5 or G6 Continuous Glucose Monitoring (CGM) and with a total CGM use ≥ 6 months in the prior year

- Participants must have been on the same type of short acting insulin (Humalog U-100 or Novolog) 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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Overall Contact

Last Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email: [email protected]

Location
Facility: Investigator:
Atlanta Diabetes Associates | Atlanta, Georgia, 30318, United States Bruce Bode Principal Investigator
Iowa Diabetes and Endocrinology Research Center | West Des Moines, Iowa, 50265, United States Anuj Bhargava Principal Investigator
HealthPartners Institute dba International Diabetes Center | Minneapolis, Minnesota, 55416, United States Richard M. Bergenstal Principal Investigator
Location Countries

United States

Verification Date

October 15, 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: LY900014 + Insulin Degludec

Type: Experimental

Description: LY9000014 and insulin degludec given subcutaneously (SC).

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov