Diabetes Mellitus, Type 2Phase 1NCT02623465
A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy
A Phase 1 study testing Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company.
Trial summary
The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. 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?
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are male or female participants with Type 2 Diabetes Mellitus (T2DM)
- Are on stable prandial insulin as a multiple daily injection regimen, plus/minus basal insulin, with or without a stable dose of metformin, for at least 3 months before screening
- Have a body mass index (BMI) no greater than 35.0 kilogram per square meter (kg/m²)
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Have or used to have health problems 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
- Are treated with a continuous subcutaneous insulin infusion (insulin pump)
About this study
Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 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.
Insulin LisproDrug
Administered subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| Part A:Insulin Lispro Test | Experimental | Individualized doses of insulin lispro test formulation administered by injection under the skin once in each of 3 periods Receives: Drug: Insulin Lispro |
| Part A:Insulin Lispro Reference | Active comparator | Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods Receives: Drug: Insulin Lispro |
| Part B:Insulin Lispro Test | Experimental | Individualized doses of insulin lispro test formulation administered by injection under the skin with each meal for 14 days Receives: Drug: Insulin Lispro |
| Part B:Insulin Lispro Reference | Active comparator | Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days Receives: Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro
(Part A) PK: AUC of Insulin Lispro
Measured: Time 0 to 5 hours post dose for each treatment on Day 1
(Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal
(Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal
Measured: Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment
Secondary outcomes (2)
(Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal
(Part A) PD: AUC of Glucose Following a Meal
Measured: Time 0 to 5 hours post meal for each treatment on Day 1
(Part B) PD: AUC of Glucose Following a Meal
(Part B) PD: AUC of Glucose Following a Meal
Measured: Time 0 to 5 hours post meal on Day1 and Day14 of study treatment
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 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
- 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
- NCT02623465
- Sponsor's protocol ID
- 15628
- Other IDs
- F3Z-FW-ITCC, 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
- Yes
- 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 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
- ClinicalTrials.gov ID
- NCT02623465
- Acronym / sponsor ID
- 15628
- Conditions
- Diabetes Mellitus, Type 2
- 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.
The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A:Insulin Lispro Test | Experimental | Drug: Insulin LisproIndividualized doses of insulin lispro test formulation administered by injection under the skin once in each of 3 periods |
| Part A:Insulin Lispro Reference | Active comparator | Drug: Insulin LisproIndividualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods |
| Part B:Insulin Lispro Test | Experimental | Drug: Insulin LisproIndividualized doses of insulin lispro test formulation administered by injection under the skin with each meal for 14 days |
| Part B:Insulin Lispro Reference | Active comparator | Drug: Insulin LisproIndividualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are male or female participants with Type 2 Diabetes Mellitus (T2DM)
- Are on stable prandial insulin as a multiple daily injection regimen, plus/minus basal insulin, with or without a stable dose of metformin, for at least 3 months before screening
- Have a body mass index (BMI) no greater than 35.0 kilogram per square meter (kg/m²)
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
- Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
Key exclusion criteria (5 listed)
- Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Have or used to have health problems 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
- Are treated with a continuous subcutaneous insulin infusion (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 |
|---|---|---|
| Insulin LisproAdministered subcutaneously (SC) | Drug | Part A:Insulin Lispro Reference, Part A:Insulin Lispro Test, Part B:Insulin Lispro Reference, Part B:Insulin Lispro Test |
Primary outcome
(Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro
Time frame: Time 0 to 5 hours post dose for each treatment on Day 1
(Part A) PK: AUC of Insulin Lispro
(Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal
Time frame: Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment
(Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal
2 secondary outcomes
(Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal
Time frame: Time 0 to 5 hours post meal for each treatment on Day 1
(Part B) PD: AUC of Glucose Following a Meal
Time frame: Time 0 to 5 hours post meal on Day1 and Day14 of study treatment
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 2, 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 7 inclusion and 5 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?
(Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro (time frame: Time 0 to 5 hours post dose for each treatment on Day 1). The study lists 2 primary outcomes in all. 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.