Phase 3
Completed N=751
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Source: ClinicalTrials.gov NCT03740919 ↗Enrolled (actual)
751
Serious AEs
1.5%
Results posted
Jan 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 — 0.09; 0.06 percentage of HbA1c — p=0.783
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 |
0.09; 0.06 | 0.783 |
| SECONDARY Change From Baseline in HbA1c (Postprandial) at Week 26 |
0.09; 0.07 | 0.867 |
| SECONDARY Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose |
26.50; 36.79; 29.70; 54.04; 63.61; 57.88 | 0.008 sig |
| SECONDARY Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose |
1.59; 2.04; 1.38; 4.48; 5.95; 6.17 | 0.220 |
| SECONDARY Percentage of Participants With Documented Hypoglycemic Events |
80.81; 81.37; 74.45; 93.98; 92.55; 87.62 | 0.864 |
| SECONDARY Rate of Documented Hypoglycemia Events |
16.6; 16.1; 17.7; 78.0; 75.1; 76.1 | 0.732 |
| SECONDARY Rate of Severe Hypoglycemia |
2.05; 2.20; 0.00 | — |
| SECONDARY Change From Baseline in Insulin Dose at Week 26 |
2.3; 2.9; 2.7; 5.3; 5.8; 5.0 | 0.130 |
| SECONDARY Percentage of Participants With HbA1c < 7.0% and <7.5% |
20.00; 21.92; 19.08; 40.00; 37.31; 32.82 | 0.396 |
| SECONDARY Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26 |
1.0; -3.4; -5.9; -3.2; -17.9; -9.8 | — |
Eligibility Criteria
Inclusion Criteria
- T1D for at least 6 months at the screening visit.
- Have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit:
- insulin lispro U-100, or
- insulin aspart
- insulin glulisine or
- fast acting insulin aspart
- Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:
- insulin glargine U-100 (once a day [QD] or twice a day [BID]), or
- insulin detemir U-100 (QD or BID), or
- insulin degludec U-100 (QD)
- Have a HbA1c value ≤ 9.9% at the screening visit.
Exclusion Criteria
- Have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit.
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.
- Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.
Data sourced from ClinicalTrials.gov (NCT03740919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.