Type I Diabetes Mellitus MedDRA version: 21.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: LY900027
Product Code: LY900027
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Other descriptive name: Humalog active substance
C
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female subject with diabetes mellitus type 1 for at least 1 year. -Age between 18 and 64 years, both inclusive. -Body Mass Index (BMI) between 18.5 and 33.0 kg/m^2, both inclusive. -HbA1c 0.4 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Previous participation in this trial. Participation is defined as randomised. -Known allergies to adhesives, NSAIDs (e.g. Meloxicam), insulin lispro, insulin glulisine (Apidra), related compounds, or any components of the IMPs used in this trial. -Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator. -Systolic blood pressure 139 mmHg and/or diastolic blood pressure 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension). -Symptoms of arterial hypotension -Heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives. -Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption. -AST and/or ALT > 2 times the upper limit of normal. -Elevated serum creatinine values above the upper limit of normal. -More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months. -Hypoglycaemic unawareness as judged by the Investigator. -Hospitalisation for diabetic ketoacidosis during the previous 6 months. -A positive result in the alcohol and/or urine drug screen at the screening visit. -Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period. -Intended use of systemic NSAIDs during the study. -Blood donation or blood loss of more than 500 mL within the last month. -If female, pregnancy or breast-feeding -Women of childbearing potential who are not using a highly effective contraceptive method until 1 month after last dosing. -Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 1 month after last dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the PK response of insulin lispro when standard bolus doses of LY900027 or Humalog are administered with an insulin pump during standardized meal tests on Days 5, 7, and 10 after catheter insertion compared to baseline on Day 3.;Secondary Objective: To evaluate the post-prandial glucodynamics (GD) when standard bolus doses of LY900027 or Humalog are administered with an insulin pump during standardized meal tests on Days 1, 3, 5, 7, and 10 after catheter insertion. To evaluate daily insulin requirements for up to 10 days after catheter insertion. To evaluate the time until catheter failure To explore safety and tolerability of LY900027. ;Primary end point(s): AUC. Ins 0-5h, area under the insulin lispro curve after bolus administration prior to an MMTTT C Ins. max, maximum observed insulin lispro concentration ;Timepoint(s) of evaluation of this end point: Days 3, 5, 7, and 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK Endpoints AUCINS_0-0.5h, AUCINS_0-1h, AUCINS_0-2h, AUCINS_0-4h, AUCINS_0-5h, area under the insulin lispro curve in the indicated time intervals after bolus administration prior to an MMTTT tmax.INS, time to maximum observed serum insulin concentration PD Endpoints ?AUCPG_0-5h, incremental area under the plasma glucose curve above baseline in the indicated time intervals after bolus infusion ?PGMAX, maximum blood glucose excursion after bolus infusion Daily insulin requirements: total daily insulin dose total daily prandial insulin doses total daily basal dose number and total daily dose of correction bolus doses Endpoints on Catheter Weartime Number of of unexplained hyperglycemic episodes with PG above 250 mg/dL Duration until catheter failure Safety Endpoints AEs Hypoglycaemic episodes Laboratory safety parameters Physical examination Vital signs ECG Local tolerability: bolus-related infusion site pain (measured by eVAS) 3D photographs to evaluate skin reactions at catheter site before insertion and after catheter removal ;Timepoint(s) of evaluation of this end point: Days 1, 3, 5, 7, and 10 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed