Diabetes
Conditions
Interventions
Subcutaneous injection of aspart insulin by jet injector versus conventional
insulin pen (simultaneous injection of placebo with the comparator pen
according to the dubble-dummy design), directly pr
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Age 18-70 years •Body-mass index 18-30 kg/m2 •Stable glycaemic control with HbA1c 6.5-9.0% •Duration of diabetes >1 year •Insulin use at least once daily or with subcutaneous pump •Blood pressure
Exclusion criteria
Exclusion criteria: •Inability to provide informed consent •Requirement of 200 *g/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample •Symptomatic diabetic neuropathy •Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) •History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) •Pregnancy or the intention to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the baseline-subtracted plasma glucose concentration time-curve from time 0 to 2 h after insulin injection and meal ingestion (BG-AUC0-2h) | — |
Secondary
| Measure | Time frame |
|---|---|
| - area under the baseline-subtracted plasma glucose concentration time-curve from time 0 to 6 h after insulin injection and meal ingestion (BG-AUC0-6h) - maximal glucose excursion after insulin injection and meal ingestion (BGmax) - time to maximal glucose excursion after insulin injection and meal ingestion (T-BGmax) - time until plasma glucose has returned to baseline values after insulin injection and meal ingestion (T-BGBL) - maximal insulin concentration (C-INSmax) - time to maximal insulin concentration (T-INSmax) - area under the insulin concentration curve (from timepoint 0) (INSAUC) - time until 50% of insulin absorption (mean residence time, MRT) (T-INSAUC50%) - Number of patients requiring exogenous glucose infusion to prevent postprandial hypoglycaemia after insulin injection and meal ingestion; - Amount of exogenous glucose required to prevent postprandial hypoglycaemia after insulin injection and meal ingestion; - Duration of time that exogenous glucose is required to prevent postprandial hypoglycaemia after insulin injection and meal ingestion. | — |
Countries
Netherlands
Outcome results
None listed