Phase 2
Completed N=31
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Source: ClinicalTrials.gov NCT04585776 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) — 71.57; 65.76; 70.18 percentage of time
Summary
In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) |
71.57; 65.76; 70.18 | — |
| SECONDARY Insulin to Carbohydrate Ratio (ICR) |
9.03; 9.07; 9.11; 9.05 | — |
| SECONDARY Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin |
52.06 | — |
| SECONDARY Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) |
411.1; 421.3; 427.6; 420.0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
- Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
- Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
- Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening
Exclusion Criteria
- Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
- Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
- Participants must not be taking certain diabetes medications that are not allowed for study participation
Data sourced from ClinicalTrials.gov (NCT04585776). 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.