Clinical trial NCT03465878: A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-03-14
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
timeFrame: 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 outcomes:
measure: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
timeFrame: -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
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Ontario
city: Hannover
country: Germany
facility: Kinderkrankenhaus auf der Bult
state: Niedersachsen
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: