A study in Type I Diabetes Mellitus
- Conditions
- Type I Diabetes MellitusMedDRA version: 21.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2019-002318-37-DE
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
-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 <= 9.0%.
-Fasting negative C-peptide (<= 0.30 nmol/L).
-Currently on stable CSII for at least 3 months prior to inclusion into the trial, with a total daily insulin dose of >0.4 and <=1.5 U/kg/day.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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 < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>To evaluate daily insulin requirements for up to 10 days after catheter insertion.<br>To evaluate the time until catheter failure<br>To explore safety and tolerability of LY900027.<br>;Primary end point(s): AUC. Ins 0-5h, area under the insulin lispro curve after bolus administration prior to an MMTTT <br>C Ins. max, maximum observed insulin lispro concentration<br>;Timepoint(s) of evaluation of this end point: Days 3, 5, 7, and 10
- Secondary Outcome Measures
Name Time Method