Type 1 DiabetesPhase 2NCT04585776

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

A Phase 2 study testing LY900014 and Insulin Degludec in people with Type 1 Diabetes, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: LY900014 and Insulin Degludec
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 3 sitesUnited States
Study dates: 30 Oct 2020to 27 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265

Other trials in United States

About this study

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

Conditions: Type 1 Diabetes
Being tested: LY900014, Insulin Degludec
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY900014Drug
Administered SC
Insulin DegludecDrug
Administered SC

Study groups in NCT04585776
Study group	Role	What they receive
LY900014 + Insulin Degludec	Experimental	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. Receives: Drug: LY900014; Drug: Insulin Degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 46

Secondary outcomes (3)

Insulin to Carbohydrate Ratio (ICR)
ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Measured: Day 46
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Prandial:TDD ratio
Measured: Day 46
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).
Measured: Day 46

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 202027 May 2021

First posted14 Oct 2020
Study start30 Oct 2020
Primary completion27 May 2021
Study completion27 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585776
Sponsor's protocol ID: 17601
Other IDs: I8B-MC-ITSZ
Status last verified: May 2022
First submitted: 8 Oct 2020
Last updated: 3 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Bergenstal RM, Bode BW, Bhargava A, Wang Q, Knights AW, Chang AM. Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes. Diabetes Ther. 2023 Nov;14(11):1933-1945. doi: 10.1007/s13300-023-01476-4. Epub 2023 Sep 23.
PubMed 37740871

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04585776
Acronym / sponsor ID: 17601
Conditions: Type 1 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 30 Oct 2020 (actual)
Primary completion: 27 May 2021 (actual)
Study completion: 27 May 2021 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 3 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY900014 + Insulin Degludec	Experimental	Drug: LY900014, Drug: Insulin DegludecLY900014 (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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY900014Administered SC	Drug	LY900014 + Insulin Degludec
Insulin DegludecAdministered SC	Drug	LY900014 + Insulin Degludec

Primary outcome

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

3 secondary outcomes

Insulin to Carbohydrate Ratio (ICR)
Time frame: Day 46
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Time frame: Day 46
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Time frame: Day 46

Results and safety

Results posted to the registry on 3 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY900014 + Insulin Degludec	31	31

Primary outcome: Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)

Time frame: Day 46. Mean (Standard Deviation). Unit: percentage of time

Measure	LY900014 + Insulin Degludec n = 31
Day-time	71.57 (14.370)
Night-time	65.76 (19.846)
24-Hour Period	70.18 (14.589)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Follow-up (Up To 53 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY900014 + Insulin Degludec	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37740871Bergenstal RM, Bode BW, Bhargava A, Wang Q, Knights AW, Chang AM. Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes. Diabetes Ther. 2023 Nov;14(11):1933-1945. doi: 10.1007/s13300-023-01476-4. Epub 2023 Sep 23.
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Related trials for Type 1 Diabetes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY900014 and Insulin Degludec in people with Type 1 Diabetes, run by Eli Lilly and Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) (time frame: Day 46). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.