Diabetes Mellitus, Type 1
Conditions
Brief summary
This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.
Interventions
BIOLOGICALInsulin Peglispro
Daily doses administered SC.
BIOLOGICALInsulin Glargine
Daily doses administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5% * Otherwise fit and healthy * Non smoker
Exclusion criteria
* Taking medication or supplements other than insulin to control diabetes. * Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia * Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VLDL-TG Oxidation Rate | Day 22: 240 min to 420 min | VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. |
| Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations | Day 22: 240 minutes (min) to 420 min | VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine. |
| VLDL-TG Secretion Rate | Day 22: 240 min to 420 min | VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. |
| VLDL-TG Clearance Rate | Day 22: 240 min to 420 min | VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. |
Countries
Denmark
Participant flow
Pre-assignment details
Insulin treatments were transitioned by gradual tapering/titration as required at the start of each period and the end of Period 2 based on the participants individual randomization and pre-study therapy.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants were randomized to receive daily stable doses of either insulin peglispro or insulin glargine (0.2 -0.8 U/kg) administered SC for at least 21 days, in one of two treatment periods. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Met exclusion criteria | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 35.3 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment Denmark | 14 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 14 | 5 / 14 |
| serious Total, serious adverse events | 0 / 14 | 1 / 14 |
Outcome results
Primary
Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
Time frame: Day 22: 240 minutes (min) to 420 min
Population: All participants who were randomized and received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations | 0.27 micromole per Liter (μmol/L) | Geometric Coefficient of Variation 55 |
| Insulin Glargine | Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations | 0.17 micromole per Liter (μmol/L) | Geometric Coefficient of Variation 66 |
Primary
VLDL-TG Clearance Rate
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Time frame: Day 22: 240 min to 420 min
Population: All participants who were randomized and received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | VLDL-TG Clearance Rate | 142.16 milliliters per minute (mL/min) | Geometric Coefficient of Variation 47 |
| Insulin Glargine | VLDL-TG Clearance Rate | 155.11 milliliters per minute (mL/min) | Geometric Coefficient of Variation 49 |
Primary
VLDL-TG Oxidation Rate
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Time frame: Day 22: 240 min to 420 min
Population: All participants who were randomized and received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | VLDL-TG Oxidation Rate | 20.13 μmol/min | Geometric Coefficient of Variation 40 |
| Insulin Glargine | VLDL-TG Oxidation Rate | 15.34 μmol/min | Geometric Coefficient of Variation 59 |
Primary
VLDL-TG Secretion Rate
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Time frame: Day 22: 240 min to 420 min
Population: All participants who were randomized and took at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Peglispro | VLDL-TG Secretion Rate | 38.79 μmol/min | Geometric Coefficient of Variation 42 |
| Insulin Glargine | VLDL-TG Secretion Rate | 25.61 μmol/min | Geometric Coefficient of Variation 58 |