Insulin by Jet-injection for Hyperglycemia in Diabetes

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Nijmegen
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• diabetes mellitus type 1 or 2

• 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

• anemia