Phase 3
Completed N=354
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Source: ClinicalTrials.gov NCT03952130 ↗Enrolled (actual)
354
Serious AEs
7.1%
Results posted
Feb 2023
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -0.28; -0.21 Percentage of HbA1c
◆ Published Evidence
Emerging
2citations · ~1 / year
Ultra-rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double-blind phase 3 study.
Summary
The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (T1D).
Linked Publications
-
Ultra-rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double-blind phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.28; -0.21 | — |
| SECONDARY 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) |
102.8; 85.0 | 0.003 sig |
| SECONDARY 2-hour PPG Excursion During MMTT |
142.2; 116.7 | 0.001 sig |
| SECONDARY Rate of Severe Hypoglycemia |
6.88; 5.87 | 0.834 |
| SECONDARY Rate of Documented Symptomatic Post Meal Hypoglycemia |
0.11; 0.09; 0.75; 1.20; 3.80; 4.52 | 0.983 |
| SECONDARY Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) |
0.39; 0.10 | 0.309 |
| SECONDARY Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values |
5.5; -10.2; -6.4; -20.4; -9.5; -24.4 | <.001 sig |
| SECONDARY Change From Baseline in Daily Insulin Dose |
0.0; 0.0; 6.0; 6.6; 6.0; 6.6 | 0.947 |
| SECONDARY Percentage of Participants With HbA1c <7% and ≤6.5% |
28.48; 26.71; 15.15; 9.94 | 0.462 |
Eligibility Criteria
Inclusion Criteria
- Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
- Participants must have HbA1c of ≥7.0 and ≤10.0%.
- Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.
- Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).
Exclusion Criteria
- Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening.
- Participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening.
- Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT03952130) and the linked publication. 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.