A Phase 3 interventional study of LY900014 and Insulin lispro in Diabetes Type 1, sponsored by Eli Lilly and Company. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
100 units per milliliter (U/mL) LY900014 administered by individualized, continuous, subcutaneous insulin infusion (CSII)
Drug: LY900014
100 U/mL insulin lispro (Humalog®) administered by individualized CSII
Drug: Insulin lispro
Administered by CSII
Also known as: Ultra-Rapid Lispro
Administered by CSII
Also known as: Humalog
Rate of Infusion Set Failures
Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure \[last dose date and time -first dose date and time -duration of pump or treatment interruption\] times 30.
Time frame: 6 Weeks
Percentage of Participants With at Least 1 Event of Infusion Set Failure
Infusion set failures are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250mg/dL (13.9 mmol/L) that does not decrease within 1 hour following a correction bolus delivered via the pump.
Time frame: 6 Weeks
Rate of Premature Infusion Set Changes
Rate of premature infusion set changes.
Time frame: 6 Weeks
Time Interval Until Infusion Set Change
Time interval until infusion set change reflects the time interval in hours until infusion set change from first to last dose. MMRM model for post-baseline measures: Variable = Baseline + Period + Sequence + Strata(Region + Historical Use of SmartGuard/Threshold Suspend + HbA1c(\<=7.3%, \>7.3%)) + Treatment (Type III sum of squares).
Time frame: 6 Weeks
Ratio of Bolus/Total Insulin Dose
The bolus and total insulin doses for each visit was calculated as the mean of the doses for the last 3 days prior to the visit date that are entered in the eCRF. The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit.
Time frame: 6 Weeks
Interstitial Glucose Reduction Rate From Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump
Interstitial glucose reduction rate (glucose reduction \[mg/dL\] per minute) within 4 hours following a non-meal-related correction bolus via the pump, from hyperglycemia (interstitial glucose \>180 mg/dL \[10 mmol/L\]) to recovery (interstitial glucose ≤180 mg/dL).
Time frame: 6 Weeks
Number of Participants With Severe Hypoglycemic Events
Number of participants with severe hypoglycemic events. Severe hypoglycemia was defined as participants with an altered mental status and could not assist in their own care, may have been semiconscious or unconscious, or experienced coma with or without seizures, and the event required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Blood glucose measurements may not have been available during such an event, but neurological recovery attributable to the restoration of BG concentration to normal was considered sufficient evidence that the event was induced by a low BG concentration (BG ≤70 mg/dL \[3.9 mmol/L\]).
Time frame: 6 Weeks
| Milestone | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) |
|---|---|---|
| Started | 24 | 25 |
| Received at least 1 dose of study drug | 24 | 25 |
| Completed | 23 | 25 |
| Not completed | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Milestone | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) |
|---|---|---|
| Started | 23 | 25 |
| Received at least 1 dose of study drug | 23 | 25 |
| Completed | 22 | 24 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure \[last dose date and time -first dose date and time -duration of pump or treatment interruption\] times 30.
| events per 30 participant days | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Rate of Infusion Set Failures | 0.05 | 0.03 |
Infusion set failures are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250mg/dL (13.9 mmol/L) that does not decrease within 1 hour following a correction bolus delivered via the pump.
| percentage of participants | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Percentage of Participants With at Least 1 Event of Infusion Set Failure | 6.3 | 4.1 |
Rate of premature infusion set changes.
| events per 30 participant days | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Rate of Premature Infusion Set Changes | 0.78 | 1.13 |
Time interval until infusion set change reflects the time interval in hours until infusion set change from first to last dose. MMRM model for post-baseline measures: Variable = Baseline + Period + Sequence + Strata(Region + Historical Use of SmartGuard/Threshold Suspend + HbA1c(\<=7.3%, \>7.3%)) + Treatment (Type III sum of squares).
| hours | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Time Interval Until Infusion Set Change | 76.1 ± 1.52 | 74.3 ± 1.51 |
The bolus and total insulin doses for each visit was calculated as the mean of the doses for the last 3 days prior to the visit date that are entered in the eCRF. The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit.
| percentage of total insulin dose | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Ratio of Bolus/Total Insulin Dose | 46.6 ± 1.17 | 44.2 ± 1.17 |
Interstitial glucose reduction rate (glucose reduction \[mg/dL\] per minute) within 4 hours following a non-meal-related correction bolus via the pump, from hyperglycemia (interstitial glucose \>180 mg/dL \[10 mmol/L\]) to recovery (interstitial glucose ≤180 mg/dL).
| mg/dL/min | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Interstitial Glucose Reduction Rate From Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump | 0.71 ± 0.062 | 0.82 ± 0.063 |
Number of participants with severe hypoglycemic events. Severe hypoglycemia was defined as participants with an altered mental status and could not assist in their own care, may have been semiconscious or unconscious, or experienced coma with or without seizures, and the event required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Blood glucose measurements may not have been available during such an event, but neurological recovery attributable to the restoration of BG concentration to normal was considered sufficient evidence that the event was induced by a low BG concentration (BG ≤70 mg/dL \[3.9 mmol/L\]).
| participants | Insulin Lispro (Humalog®) | LY900014 |
|---|---|---|
| Number of Participants With Severe Hypoglycemic Events | 1 | 1 |
Collected over up to 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY900014 | 0/49 (0%) | 1/49 (2%) | 18/49 (36.7%) |
| Insulin Lispro (Humalog®) | 0/48 (0%) | 1/48 (2.1%) | 6/48 (12.5%) |
| Event | LY900014 | Insulin Lispro (Humalog®) |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 1/49 | 1/48 |
| Event | LY900014 | Insulin Lispro (Humalog®) |
|---|---|---|
| Infusion site painGeneral disorders | 9/49 | 2/48 |
| Infusion site reactionGeneral disorders | 9/49 | 4/48 |
All randomized participants.
| Age, Continuous(years) | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) | Total |
|---|---|---|---|
| Mean | 42.50 ± 12.47 | 36.72 ± 10.37 | 39.55 ± 11.69 |
| Sex: Female, Male(Participants) | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) | Total |
|---|---|---|---|
| Female | 12 | 14 | 26 |
| Male | 12 | 11 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 23 | 25 | 48 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 23 | 25 | 48 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Sequence 1 (LY900014/Insulin Lispro) | Sequence 2 (Insulin Lispro/LY900014) | Total |
|---|---|---|---|
| United States | 10 | 11 | 21 |
| Spain | 14 | 14 | 28 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin Lispro