Diabetes Mellitus, Type 1Phase 1NCT02623478
A Study of a Novel Insulin Lispro Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps
A Phase 1 study testing Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company.
Trial summary
This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
- Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
- Have venous access sufficient to allow for blood sampling
- Have provided written consent and are willing to follow study procedures and commit to the study duration
Who cannot join
- Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study
- Had blood loss of more than 500 milliliters (mL) within the last month
About this study
Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin Lispro
- 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.
Insulin LisproDrug
Also called Humalog
Administered subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| Insulin Lispro - Test Formulation | Experimental | Novel formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods Receives: Drug: Insulin Lispro |
| Insulin Lispro - Reference Formulation | Active comparator | Marketed formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods Receives: Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro
PK: AUC of Insulin Lispro
Measured: Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period
Secondary outcomes (1)
Pharmacodynamics (PD): AUC of Glucose Following a Meal
PD: AUC of Glucose Following a Meal
Measured: Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startJan 2018 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Change in clinical strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT02623478
- Sponsor's protocol ID
- 15639
- Other IDs
- F3Z-FW-ITCD, 2015-003353-18, 2015
- Status last verified
- Jul 2017
- First submitted
- 3 Dec 2015
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
- ClinicalTrials.gov ID
- NCT02623478
- Acronym / sponsor ID
- 15639
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in clinical strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2018 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Lispro - Test Formulation | Experimental | Drug: Insulin LisproNovel formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods |
| Insulin Lispro - Reference Formulation | Active comparator | Drug: Insulin LisproMarketed formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
- Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
- Have venous access sufficient to allow for blood sampling
Key exclusion criteria (4 listed)
- Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study
- Had blood loss of more than 500 milliliters (mL) within the last month
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 |
|---|---|---|
| Insulin LisproAlso: HumalogAdministered subcutaneously (SC) | Drug | Insulin Lispro - Reference Formulation, Insulin Lispro - Test Formulation |
Primary outcome
Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro
Time frame: Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period
PK: AUC of Insulin Lispro
1 secondary outcome
Pharmacodynamics (PD): AUC of Glucose Following a Meal
Time frame: Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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): Area under the Concentration Curve (AUC) of Insulin Lispro (time frame: Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period). 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 13 Jul 2017.