Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood concentrations of the administered trial drug) of faster-acting insulin aspart (faster aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the safety and tolerability of faster aspart and NovoRapid® will also be assessed. The participants will be in the study for approx. 21 days. Each participant will have 5 visits to the clinic, with an overnight stay at both dosing visits. Participants will have a number of tests, and they will have to give blood and urine samples.
Interventions
DRUGFaster-acting insulin aspart
In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
DRUGInsulin aspart
In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 - 64 years (both inclusive) at the time of signing informed consent. * Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer. * Body mass index 18.5 - 28.0 kg/sqm (both inclusive). * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer.
Exclusion criteria
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening. * Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily). * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 30 min | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous subcutaneous infusion related time from bolus to max insulin aspart concentration | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 15 min. | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 1 hour | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 1,5 hour | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 2 hours | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to first time the curve is back to baseline | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 2 hours to first time the curve is back to baseline | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related time from bolus to late 50% of max insulin aspart concentration | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on plasma insulin measured in serum |
| Continuous subcutaneous infusion related time from bolus to max baseline corrected insulin aspart concentration | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related time from bolus administration to 50% of max baseline corrected Glucose Infusion Rate | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related time from bolus administration to max of baseline corrected Glucose Infusion Rate | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related time from bolus to 50% of max insulin aspart concentration | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours | Calculated based on insulin aspart measured in serum |
| Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 1 hour | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 1,5 hour | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 2 hours | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to first time the curve is back to baseline | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 2 hours to first time the curve is back to baseline | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Area under the glucose infusion rate curve based on concentrations from -2 to 0 hours | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Area under the glucose infusion rate curve based on concentrations from 12 to 14 hours | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related max of baseline corrected Glucose Infusion Rate | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Continuous subcutaneous infusion related time from bolus to late 50% of max baseline corrected glucose infusion rate | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
| Number of adverse events ( AEs) | Day 1-21 | Count of events |
| Number of hypoglycaemic episodes | Day 1-21 | Count of episodes |
| Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 30 min | Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours | Calculated based on glucose infusion |
Countries
Germany
Outcome results
None listed