Phase 2
Completed N=42
A Study of LY900014 in a Medtronic Pump
Type1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03760640 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour) — 76.98; 77.84 Percentage of Time — p=0.339
Summary
The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour) |
76.98; 77.84 | 0.339 |
| SECONDARY Mean Sensor Glucose Value (24-Hour) |
148.64; 145.64 | 0.011 sig |
| SECONDARY Percentage of Time Spent in Auto Mode |
91.98; 91.42 | 0.557 |
| SECONDARY Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour) |
0.34; 0.38 | 0.548 |
| SECONDARY Rate of Severe Hypoglycemic Events |
0; 0 | — |
| SECONDARY Total Daily Insulin Dose |
42.59; 42.10 | 0.577 |
Eligibility Criteria
Inclusion Criteria
- Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
- Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
- Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
- Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
- Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time
Exclusion Criteria
- Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
- Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
- Participants must not have a total daily insulin dose >100 units
- Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
- Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder
Data sourced from ClinicalTrials.gov (NCT03760640). 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.