A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449433
• Other study ID #: 16911
• Secondary ID: I8B-MC-ITSL2017-
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2018
• Est. completion date: August 14, 2018

Study information

• Verified date: September 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

• Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)

• Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

• Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

• Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• LY900014
Administered SC
• Insulin Lispro
Administered SC
• Insulin Aspart
Administered SC
• Insulin Aspart
Administered SC

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen

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	Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm	PK: Insulin Lispro or Insulin Aspart AUC(0-7h)	0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose
Secondary	Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)	PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)	Time Frame:-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