Insulin by Jet-injection for Hyperglycemia in Diabetes

NCT ID: NCT01947556

Last Updated: 2014-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-11-30

Brief 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

Detailed Description

Recently, we showed in both healthy, non-diabetic volunteers and in patients with type 1 (T1DM) and insulin-treated type 2 diabetes (T2DM) a 40-50% faster absorption of rapid-acting insulin analogues when administered by jet injection technology rather than by conventional insulin pen. The faster insulin action of insulin administration by jet injection may be especially advantageous for correction of hyperglycemia.

To investigate this, a open-label randomised controlled cross-over study will be performed in 20 adult patients (18-75 years) with T1DM or T2DM on basal-bolus insulin treatment.

The pharmacokinetic and pharmacodynamic profile of insulin aspart will be derived from the time-action profiles of insulin and glucose, respectively, in response to insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) after reaching hyperglycemia (18-23 mmol/l). All patients will be investigated twice, where on one occasion the jet-injector device will be used to inject insulin, and on the other occasion insulin will be injected with a conventional insulin pen. The order of these occasions will be randomised. Both devices will be operated by the patient after sufficient training. Ease of use will be evaluated.

Conditions

Diabetes Mellitus

Keywords

diabetes; insulin administration; hyperglycaemia; insulin aspart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

insujet is tested first

first procedure: experiment with the investigational product (Insujet pen)containing insulin aspart; second procedure: control device (conventional Novopen III insulin pen) contains insulin aspart.

Group Type: OTHER

insulin aspart

Intervention Type: DRUG

After hyperglycaemia (18-23 mmol/l) has been reached (by decreasing or interrupting exogenous insulin administration 12-24 hours before the experiment), aspart insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) will be administered subcutaneously by Insujet pen or conventional insulin pen, on two separate occasions, or vice versa. The injection will be given by the subject under supervision of the research staff.

insujet is tested second

first procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart.

Group Type: OTHER

insulin aspart

Intervention Type: DRUG

After hyperglycaemia (18-23 mmol/l) has been reached (by decreasing or interrupting exogenous insulin administration 12-24 hours before the experiment), aspart insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) will be administered subcutaneously by Insujet pen or conventional insulin pen, on two separate occasions, or vice versa. The injection will be given by the subject under supervision of the research staff.

Interventions

insulin aspart

After hyperglycaemia (18-23 mmol/l) has been reached (by decreasing or interrupting exogenous insulin administration 12-24 hours before the experiment), aspart insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) will be administered subcutaneously by Insujet pen or conventional insulin pen, on two separate occasions, or vice versa. The injection will be given by the subject under supervision of the research staff.

Intervention Type: DRUG

Other Intervention Names

Novorapid

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Nijmegen

OTHER

Sponsor Role: lead

Responsible Party

HM de Wit

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bastiaan de Galan, MD PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

PKPD_INSJ_3

Identifier Type: -

Identifier Source: org_study_id