Diabetes Mellitus, Type 2Phase 1NCT03341312
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing LY900014 and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY900014 and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Nov 2017to 31 Mar 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
- Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
- Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
- Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening
Who cannot join
- Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
- Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
- Are treated with a CSII (insulin pump)
- Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight (U/kg/body weight)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Mainz
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Neuss
About this study
Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T2DM
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY900014, Insulin Lispro
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY900014Biological
Also called Ultra-Rapid Lispro
Administered SC
Insulin LisproBiological
Also called LY275585, Humalog
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY900014 Before Meal | Experimental | Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. Receives: Biological: LY900014 |
| LY900014 After Meal | Experimental | Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. Receives: Biological: LY900014 |
| Insulin Lispro (Humalog) Before Meal | Active comparator | Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods. Receives: Biological: Insulin Lispro |
| Insulin Lispro (Humalog) After Meal | Active comparator | Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods. Receives: Biological: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)
PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Measured: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose
Secondary outcomes (1)
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start13 Nov 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
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 2Studies 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
- 36 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
- NCT03341312
- Sponsor's protocol ID
- 16642
- Other IDs
- I8B-MC-ITRW, 2017-001501-33, 2017
- Status last verified
- Apr 2018
- First submitted
- 9 Nov 2017
- Last updated
- 9 Jun 2020
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T2DM
- ClinicalTrials.gov ID
- NCT03341312
- Acronym / sponsor ID
- 16642
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY900014 Before Meal | Experimental | Biological: LY900014Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. |
| LY900014 After Meal | Experimental | Biological: LY900014Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. |
| Insulin Lispro (Humalog) Before Meal | Active comparator | Biological: Insulin LisproIndividualized dose of insulin lispro administered SC immediately before meal in one of four study periods. |
| Insulin Lispro (Humalog) After Meal | Active comparator | Biological: Insulin LisproIndividualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
- Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
- Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
- Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening
Key exclusion criteria (6 listed)
- Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
- Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
- Are treated with a CSII (insulin pump)
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 |
|---|---|---|
| LY900014Also: Ultra-Rapid LisproAdministered SC | Biological | LY900014 After Meal, LY900014 Before Meal |
| Insulin LisproAlso: LY275585, HumalogAdministered SC | Biological | Insulin Lispro (Humalog) After Meal, Insulin Lispro (Humalog) Before Meal |
Primary outcome
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)
Time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose
PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
1 secondary outcome
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY900014 and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in Germany.
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 6 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 9 Jun 2020). 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?
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr) (time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose). 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 9 Jun 2020.