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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04585776
• Collaborator: (none)
• Enrollment: 31
• Locations: 3
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site: 10.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: LY900014; Drug: Insulin Degludec	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 30, 2020
• Actual Primary Completion Date: May 27, 2021
• Actual Study Completion Date: May 27, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: LY900014; Administered SC; Drug: Insulin Degludec; Administered SC

Outcome Measures

Primary Outcome Measures

1. Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) [Day 46]

   Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.

Secondary Outcome Measures

1. Insulin to Carbohydrate Ratio (ICR) [Day 46]

   ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.

2. Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin [Day 46]

   Prandial:TDD ratio

3. Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) [Day 46]

   ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
2	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa	United States	50265
3	HealthPartners Institute dba International Diabetes Center	Minneapolis	Minnesota	United States	55416

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Nov 24, 2020
• Statistical Analysis Plan - Oct 5, 2020

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04585776
• Other Study ID Numbers: 17601; I8B-MC-ITSZ
• First Posted: Oct 14, 2020
• Last Update Posted: Jun 3, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin

Study Results

Participant Flow

Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	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.
Period Title: Overall Study
STARTED	31
Received Atleast 1 Dose of Study Drug	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	LY900014 (100 U/mL) is a prandial insulin administered 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 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.
Overall Participants	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.20 (13.75)
Sex: Female, Male (Count of Participants)
Female	18 58.1%
Male	13 41.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.2%
Not Hispanic or Latino	30 96.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 3.2%
White	30 96.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	31 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had post-baseline sensor glucose values.

Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	LY900014 (100 U/mL) is a prandial insulin administered 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 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.
Measure Participants	31
Day-time	71.57 (14.370)
Night-time	65.76 (19.846)
24-Hour Period	70.18 (14.589)

2. Secondary Outcome

Title	Insulin to Carbohydrate Ratio (ICR)
Description	ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Time Frame	Day 46

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had post-baseline ICR values.

Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	LY900014 (100 U/mL) is a prandial insulin administered 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 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.
Measure Participants	31
Breakfast	9.03 (3.490)
Lunch	9.07 (3.423)
Dinner	9.11 (3.529)
Across meals	9.05 (3.398)

3. Secondary Outcome

Title	Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Description	Prandial:TDD ratio
Time Frame	Day 46

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had post-baseline values for prandial and total daily insulin dose.

Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	LY900014 (100 U/mL) is a prandial insulin administered 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 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.
Measure Participants	29
Mean (Standard Deviation) [percentage of insulin dose]	52.06 (12.282)

4. Secondary Outcome

Title	Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Description	ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Time Frame	Day 46

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had post-baseline values for ICR and TDD.

Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	LY900014 (100 U/mL) is a prandial insulin administered 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 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.
Measure Participants	29
Breakfast	411.1 (169.77)
Lunch	421.3 (184.18)
Dinner	427.6 (206.98)
Across meals	420.0 (183.52)

Adverse Events

Time Frame	Baseline to Follow-up (Up To 53 days)
Adverse Event Reporting Description	All participants who received at least one dose of study drug.
Arm/Group Title	LY900014 + Insulin Degludec
Arm/Group Description	LY900014 (100 U/mL) is a prandial insulin administered 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 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.
All Cause Mortality
	LY900014 + Insulin Degludec
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Serious Adverse Events
	LY900014 + Insulin Degludec
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	LY900014 + Insulin Degludec
	Affected / at Risk (%)	# Events
Total	0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.