A Phase 1 interventional study of LY2963016 and Lantus in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-10-07.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
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.
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Exclusion Criteria:
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.
Drug: LY2963016
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
Drug: Lantus
Single 0.3 U/kg dose administered subcutaneously
Single 0.3 U/kg dose administered subcutaneously
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.
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
| Milestone | LY2963016/Lantus | Lantus/LY2963016 |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | LY2963016/Lantus | Lantus/LY2963016 |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| hours (hr) | LY2963016 | Lantus |
|---|---|---|
| Pharmacodynamics: Duration of Action of LY2963016 and Lantus | 37.13 (2.8 to 40.5) | 40.00 (2.0 to 41.5) |
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.
| milligrams/kilogram/minute (mg/kg/min) | LY2963016 | Lantus |
|---|---|---|
| Maximum Glucose Infusion Rate (Rmax) | 0.530 ± 254 | 0.611 ± 310 |
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.
| milligrams/kilogram (mg/kg) | LY2963016 | Lantus |
|---|---|---|
| Total Glucose Infused (Gtot) | 4.60 ± 1090 | 6.52 ± 1160 |
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.
| hours (hr) | LY2963016 | Lantus |
|---|---|---|
| Time of Maximum Glucose Infusion Rate (tRmax) | 9.90 (1.50 to 30.1) | 11.7 (1.00 to 29.6) |
Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
No measurements were reported for this outcome.
AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2963016 | — | 0/20 (0%) | 4/20 (20%) |
| Lantus | — | 0/20 (0%) | 3/20 (15%) |
| Event | LY2963016 | Lantus |
|---|---|---|
| HeadacheNervous system disorders | 1/20 | 2/20 |
| Abdominal pain upperGastrointestinal disorders | 1/20 | 0/20 |
| NauseaGastrointestinal disorders | 1/20 | 0/20 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/20 | 0/20 |
| Back painMusculoskeletal and connective tissue disorders | 1/20 | 1/20 |
| DizzinessNervous system disorders | 1/20 | 0/20 |
All randomized participants.
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 41.5 ± 9.1 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 0 |
| Male | 20 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| Germany | 20 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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