A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465878
• Other study ID #: 16695
• Secondary ID: I8B-MC-ITSA2017-
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2018
• Est. completion date: November 14, 2019

Study information

• Verified date: December 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 64 Years

Eligibility

Inclusion Criteria:

• Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year

• Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion Criteria:

• Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening

• More than one episode of severe hypoglycaemia in the last 6 months

• Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency

• Have obvious clinical signs or symptoms of liver disease

• Have a history of renal impairment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• LY900014
Administered via SC injection
• Insulin Lispro
Administered via SC injection

Locations

Country	Name	City	State
Canada	LMC Endocrinology Centres Ltd.	Toronto	Ontario
Germany	Kinderkrankenhaus auf der Bult	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part	Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.	Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose
Secondary	Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part	Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG?AUC(0-5h)) Following Each Treatment Arm for Each Study Part.	-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose

External Links

•   A Study of LY900014 in Participants With Type 1 Diabetes Mellitus