Diabetes Mellitus, Type 1Phase 1NCT05262387
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
A Phase 1 study testing Lyumjev with 50% basal rate reduction, Humalog with 50% basal rate reduction and Humalog with 100% basal rate reduction in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Canada.
Trial summary
This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Lyumjev with 50% basal rate reduction, Humalog with 50% basal rate reduction and Humalog with 100% basal rate reduction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2022to 7 Mar 2023
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants with type 1 diabetes
- Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive
- Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
- Using CSII and stable insulin regimen for at least 6 months prior to inclusion into the trial
- Able to undergo at least 1 hour of moderate-intensity exercise
Who cannot join
- Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have a blood loss of more than 500 milliliters (mL) within the last month
- Have known allergies to insulin lispro, related compounds or any components of the study drug formulation
- Have previously participated or withdrawn from this study
- Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Participants who have an abnormal blood pressure and/or pulse rate
- Participants with clinically significant cardiac or pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Basal Rate Reduction With LyumjevTM Versus Humalog® on the Protection From Exercise-Induced Hypoglycemia in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Lyumjev with 50% basal rate reduction, Humalog with 50% basal rate reduction, Humalog with 100% basal rate reduction, Lyumjev with 100% basal rate reduction
- Keywords
- Lyumjev, Humalog®, Insulin lispro, Exercise, Continuous Subcutaneous Insulin Infusion, Glycemic control, Hypoglycemia, Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyumjev with 50% basal rate reductionDrug
Also called LY900014
Administered SC.
Humalog with 50% basal rate reductionDrug
Also called Insulin Lispro
Administered SC.
Humalog with 100% basal rate reductionDrug
Also called Insulin Lispro
Administered SC.
Lyumjev with 100% basal rate reductionDrug
Also called LY900014
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1: ADBC | Experimental | Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. Receives: Drug: Lyumjev with 50% basal rate reduction; Drug: Humalog with 50% basal rate reduction; Drug: Humalog with 100% basal rate reduction; Drug: Lyumjev with 100% basal rate reduction |
| Treatment Sequence 2: BACD | Experimental | Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. Receives: Drug: Lyumjev with 50% basal rate reduction; Drug: Humalog with 50% basal rate reduction; Drug: Humalog with 100% basal rate reduction; Drug: Lyumjev with 100% basal rate reduction |
| Treatment Sequence 3: CBDA | Experimental | Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. Receives: Drug: Lyumjev with 50% basal rate reduction; Drug: Humalog with 50% basal rate reduction; Drug: Humalog with 100% basal rate reduction; Drug: Lyumjev with 100% basal rate reduction |
| Treatment Sequence 4: DCAB | Experimental | Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. Receives: Drug: Lyumjev with 50% basal rate reduction; Drug: Humalog with 50% basal rate reduction; Drug: Humalog with 100% basal rate reduction; Drug: Lyumjev with 100% basal rate reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.
Measured: Start (0 minute) to end of exercise (60 minutes)
Secondary outcomes (1)
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT)
The outcome measure was analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, and period as fixed effects, and participant-within-sequence will be included as a random effect.
Measured: Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start14 Feb 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
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.
- Other trials for Diabetes Mellitus, Type 1Studies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262387
- Sponsor's protocol ID
- 17278
- Other IDs
- I8B-MC-ITSU
- Status last verified
- Aug 2024
- First submitted
- 24 Feb 2022
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Basal Rate Reduction With LyumjevTM Versus Humalog® on the Protection From Exercise-Induced Hypoglycemia in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
- ClinicalTrials.gov ID
- NCT05262387
- Acronym / sponsor ID
- 17278
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Lyumjev, Humalog®, Insulin lispro, Exercise, Continuous Subcutaneous Insulin Infusion, Glycemic control, Hypoglycemia, Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1: ADBC | Experimental | Drug: Lyumjev with 50% basal rate reduction, Drug: Humalog with 50% basal rate reduction, Drug: Humalog with 100% basal rate reduction, Drug: Lyumjev with 100% basal rate reductionPeriod 1: Lyumjev with 50% basal rate reduction (Treatment A) Period 2: Humalog with 100% basal rate reduction (Treatment D) Period 3: Lyumjev with 100% basal rate reduction (Treatment B) Period 4: Humalog with 50% basal rate reduction (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Treatment Sequence 2: BACD | Experimental | Drug: Lyumjev with 50% basal rate reduction, Drug: Humalog with 50% basal rate reduction, Drug: Humalog with 100% basal rate reduction, Drug: Lyumjev with 100% basal rate reductionPeriod 1: Lyumjev with 100% basal rate reduction (Treatment B) Period 2: Lyumjev with 50% basal rate reduction (Treatment A) Period 3: Humalog with 50% basal rate reduction (Treatment C) Period 4: Humalog with 100% basal rate reduction (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Treatment Sequence 3: CBDA | Experimental | Drug: Lyumjev with 50% basal rate reduction, Drug: Humalog with 50% basal rate reduction, Drug: Humalog with 100% basal rate reduction, Drug: Lyumjev with 100% basal rate reductionPeriod 1: Humalog with 50% basal rate reduction (Treatment C) Period 2: Lyumjev with 100% basal rate reduction (Treatment B) Period 3: Humalog with 100% basal rate reduction (Treatment D) Period 4: Lyumjev with 50% basal rate reduction (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Treatment Sequence 4: DCAB | Experimental | Drug: Lyumjev with 50% basal rate reduction, Drug: Humalog with 50% basal rate reduction, Drug: Humalog with 100% basal rate reduction, Drug: Lyumjev with 100% basal rate reductionPeriod 1: Humalog with 100% basal rate reduction (Treatment D) Period 2: Humalog with 50% basal rate reduction (Treatment C) Period 3: Lyumjev with 50% basal rate reduction (Treatment A) Period 4: Lyumjev with 100% basal rate reduction (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female participants with type 1 diabetes
- Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive
- Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
- Using CSII and stable insulin regimen for at least 6 months prior to inclusion into the trial
- Able to undergo at least 1 hour of moderate-intensity exercise
Key exclusion criteria (7 listed)
- Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have a blood loss of more than 500 milliliters (mL) within the last month
- Have known allergies to insulin lispro, related compounds or any components of the study drug formulation
- Have previously participated or withdrawn from this study
- Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
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 |
|---|---|---|
| Lyumjev with 50% basal rate reductionAlso: LY900014Administered SC. | Drug | Treatment Sequence 1: ADBC, Treatment Sequence 2: BACD, Treatment Sequence 3: CBDA, Treatment Sequence 4: DCAB |
| Humalog with 50% basal rate reductionAlso: Insulin LisproAdministered SC. | Drug | Treatment Sequence 1: ADBC, Treatment Sequence 2: BACD, Treatment Sequence 3: CBDA, Treatment Sequence 4: DCAB |
| Humalog with 100% basal rate reductionAlso: Insulin LisproAdministered SC. | Drug | Treatment Sequence 1: ADBC, Treatment Sequence 2: BACD, Treatment Sequence 3: CBDA, Treatment Sequence 4: DCAB |
| Lyumjev with 100% basal rate reductionAlso: LY900014Administered SC. | Drug | Treatment Sequence 1: ADBC, Treatment Sequence 2: BACD, Treatment Sequence 3: CBDA, Treatment Sequence 4: DCAB |
Primary outcome
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
Time frame: Start (0 minute) to end of exercise (60 minutes)
Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.
1 secondary outcome
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT)
Time frame: Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lyumjev with 50% basal rate reduction, Humalog with 50% basal rate reduction and Humalog with 100% basal rate reduction in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Canada.
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 5 inclusion and 7 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 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sep 2024). 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?
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise (time frame: Start (0 minute) to end of exercise (60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024.