Phase 3
Completed N=471
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Source: ClinicalTrials.gov NCT03830281 ↗Enrolled (actual)
471
Serious AEs
3.4%
Results posted
Jan 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16 — -0.09; -0.06 Percentage of HbA1c — p=0.565
Summary
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16 |
-0.09; -0.06 | 0.565 |
| SECONDARY Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16 |
-2.2; -26.3 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16 |
-4.2; -32.0 | < 0.001 sig |
| SECONDARY Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16 |
58.6; 59.3; 57.5; 57.9 | 0.532 |
| SECONDARY Rate of Severe Hypoglycemia at Week 16 |
2.95; 6.36 | — |
| SECONDARY Rate of Documented Symptomatic Hypoglycemia at Week 16 |
30.7; 24.6 | — |
| SECONDARY Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16 |
0.16; 0.11 | — |
| SECONDARY Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16 |
0.2; 0.5; -3.1; -12.9; -2.7; -2.9 | — |
| SECONDARY Change From Baseline in Insulin Dose at Week 16 |
-0.2; -0.1; 0.8; -1.0; 0.6; -1.1 | — |
| SECONDARY Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16 |
0.6; -1.3 | — |
| SECONDARY Percentage of Participants With HbA1c <7% |
20.77; 18.85 | — |
| SECONDARY Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change |
12.7; 14.8 | — |
| SECONDARY Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change |
18.4; 16.3 | — |
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with T1D and continuously using insulin for at least 1 year
- Have been using CSII therapy for a minimum of 6 months
- Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
- Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days
Exclusion Criteria
- Have hypoglycemia unawareness
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Data sourced from ClinicalTrials.gov (NCT03830281). 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.