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 Clinical Trial

Official title:

Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276207
• Other study ID #: 17277
• Secondary ID: I8B-MC-ITST2019-
• Status: Completed
• Phase: Phase 1
• Start date: February 25, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• LY900014
Administered by CSII
• Insulin Lispro
Administered by CSII

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co. KG	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus	Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).	Day 1: Baseline up to 5 hours after missed meal bolus
Primary	Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension	Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.	Day 2: Baseline up to 5 hours after pump suspension
Secondary	Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)	PD: PGmax following administration of LY900014 and insulin lispro (Humalog)	Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension
Secondary	Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)	PK: Tmax following administration of LY900014 and insulin lispro (Humalog)	Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension