Diabetes Mellitus, Type 1Phase 1NCT01600950
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
A Phase 1 study testing LY2963016 and Lantus in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- LY2963016 and Lantus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Jul 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
- have had a duration of diabetes ≥1 year
- have hemoglobin A1c ≤10.0%
- have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
- have a body mass index ≤29 kilograms per square meter (kg/m²)
- have venous access sufficient to allow blood sampling and cannulation for clamp procedures
Who cannot join
- are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
- have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
- have a history of proliferative retinopathy
- have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
- have an electrocardiogram (ECG) reading considered outside the normal limits
- have an abnormal blood pressure
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- have abnormal clinical laboratory tests
- have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
- show evidence of significant active neuropsychiatric disease
- regular use of known drugs of abuse and/or show positive findings on drug screening
- show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- are women with a positive pregnancy test or women who are lactating
- have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
- had more than 1 episode of severe hypoglycemia within 6 months prior to study
- undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
- had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
- are receiving systemic glucocorticoid therapy
- have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
- show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
- smoke more than 10 cigarettes (or equivalent other tobacco products) per day
Trial locations and contacts
1 site in 1 country.
Germany1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Neuss, 41460
About this study
Official title: Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- LY2963016, Lantus
- 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.
LY2963016Drug
Single 0.3 U/kg dose administered subcutaneously
LantusDrug
Single 0.3 U/kg dose administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| LY2963016 | Experimental | A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days. Receives: Drug: LY2963016 |
| Lantus | Active comparator | A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days. Receives: Drug: Lantus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
Measured: Periods 1 and 2: Baseline up to 42 hours postdose
Secondary outcomes (5)
Maximum Glucose Infusion Rate (Rmax)
Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.
Measured: Periods 1 and 2: Baseline up to 42 hours postdose
Total Glucose Infused (Gtot)
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.
Measured: Periods 1 and 2: Baseline up to 42 hours postdose
Time of Maximum Glucose Infusion Rate (tRmax)
tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Measured: Periods 1 and 2: Baseline up to 42 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Measured: Periods 1 and 2: Baseline up to 42 hours postdose
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Measured: Periods 1 and 2: Baseline up to 42 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT01600950
- Sponsor's protocol ID
- 13831
- Other IDs
- I4L-MC-ABEE
- Status last verified
- Oct 2014
- First submitted
- 15 May 2012
- Last updated
- 7 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01600950
- Acronym / sponsor ID
- 13831
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 | Experimental | Drug: LY2963016A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days. |
| Lantus | Active comparator | Drug: LantusA single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
- have had a duration of diabetes ≥1 year
- have hemoglobin A1c ≤10.0%
- have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
- have a body mass index ≤29 kilograms per square meter (kg/m²)
Key exclusion criteria (23 listed)
- are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
- have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
- have a history of proliferative retinopathy
- have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
- have an electrocardiogram (ECG) reading considered outside the normal limits
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 |
|---|---|---|
| LY2963016Single 0.3 U/kg dose administered subcutaneously | Drug | LY2963016 |
| LantusSingle 0.3 U/kg dose administered subcutaneously | Drug | Lantus |
Primary outcome
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
5 secondary outcomes
Maximum Glucose Infusion Rate (Rmax)
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
Total Glucose Infused (Gtot)
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
Time of Maximum Glucose Infusion Rate (tRmax)
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 LY2963016 and Lantus in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site 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 6 inclusion and 23 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 7 Oct 2014. 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 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 7 Oct 2014). 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: Duration of Action of LY2963016 and Lantus (time frame: Periods 1 and 2: Baseline up to 42 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 7 Oct 2014.