Phase 1
Completed N=32
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT04276207 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus — 1.79; 2.55 Hours — p=0.1450
Summary
The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus |
1.79; 2.55 | 0.1450 |
| PRIMARY Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension |
1.53; 1.78 | 0.0010 sig |
| SECONDARY Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog) |
297; 309; 259; 265 | 0.0173 sig |
| SECONDARY Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog) |
0.75; 0.83; 0.92; 0.92 | 0.945 |
Eligibility Criteria
Inclusion Criteria
- Male or female participants with type 1 diabetes
- Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
- Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
- Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial
Exclusion Criteria
- Known or suspected hypersensitivity to investigational medical product(s) or related products
- Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
- Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
- Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
- Widespread subcutaneous lipodystrophy in the abdomen
- Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
- Chronic or recent use of corticosteroids
Data sourced from ClinicalTrials.gov (NCT04276207). 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.