The effect of rapid-acting insulin injected by needle-free jet-injection in the management of hyperglycemia in patients with diabetes

Completed

Conditions: diabetes
10018424

Registration Number: NL-OMON38926

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age 18-75 years

- Body-Mass Index >=25 kg/m2 and <=40 kg/m2

- Stable glycaemic control with HbA1c >=48 (6.5%) and <=86 mmol/mol (10%)

- Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed

Exclusion Criteria

- Inability to provide informed consent

- Insulin requirement of <34 or >200 units per day

- Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs

- Known allergy to aspart insulin

- Use of oral antidiabetic drugs other than metformin

- Symptomatic diabetic neuropathy

- History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months

- Pregnancy or the intention to become pregnant

- Renal disease (creatinine >150 µmol/l or MDRD-GFR <30 ml/min/1.73m2)

- Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)

- Presence of any other medical condition that might interfere with the study protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The time in minutes until plasma glucose concentration has dropped with >=10<br /><br>mmol/l. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The time until plasma glucose values drop below 8 and 5 mmol/l, the slope of<br /><br>the glucose fall, the area under the time-glucose curve from time 0 to 2h and 0<br /><br>to 6h, (time to) maximal insulin concentration, total duration of<br /><br>hyperinsulinaemia, area under the insulin concentration curve and time until<br /><br>50% of insulin absorption. </p><br>