- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01947556
Insulin by Jet-injection for Hyperglycemia in Diabetes
The Effect of Rapid-acting Insulin Injected by Needle-free Jet-injection in the Management of Hyperglycemia in Patients With Diabetes
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nijmegen, Netherlands, 6500HB
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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.
|
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.
Other Names:
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OTHER: 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T-BG≥10
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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the time in minutes until plasma glucose concentration has dropped with ≥ 10mmol/l (T-BG≥10).
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participants will be followed for the duration of the study, an expected average of 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T-BG5 and 8 (min)
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
|
the time in minutes until plasma glucose values drop below 8 an 5 mmol/l, respectively
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participants will be followed for the duration of the study, an expected average of 4 weeks
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Rfall
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
|
the slope of the glucose fall (mmol • l-1 • min-1), calculated from the time- glucose curve
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participants will be followed for the duration of the study, an expected average of 4 weeks
|
BG-AUC 0-2h
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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the area under the time-glucose curve, reflecting post-injection hyperglycaemic burden, from 0 to 2h after insulin injection.
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participants will be followed for the duration of the study, an expected average of 4 weeks
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BG-AUC 0-6h
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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the area under the time-glucose curve (mmol • min-1 • l-1), from 0 to 6h after insulin injection.
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participants will be followed for the duration of the study, an expected average of 4 weeks
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C-INSmax (pmol/l)
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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maximal insulin concentration
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participants will be followed for the duration of the study, an expected average of 4 weeks
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T-INSmax
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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time to maximal insulin concentration in minutes(C-INSmax)
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participants will be followed for the duration of the study, an expected average of 4 weeks
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T-INSBL
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
|
the time until plasma insulin values drop below baseline values (minutes)
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participants will be followed for the duration of the study, an expected average of 4 weeks
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INSAUC
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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area under the insulin concentration curve (pmol • min-1 • l-1)(from timepoint 0), reflects total insulin absorption
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participants will be followed for the duration of the study, an expected average of 4 weeks
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T-INSAUC50%
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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time until 50% of insulin absorption in minutes(mean residence time, MRT)
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participants will be followed for the duration of the study, an expected average of 4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS pain
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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The amount of discomfort or pain and the ease of use experienced with the two administration methods using a numeric rating scale from 0 to 10 (will be administered 30 minutes after insulin administration)
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participants will be followed for the duration of the study, an expected average of 4 weeks
|
hypoglycaemia
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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Number of patients requiring exogenous glucose infusion to prevent hypoglycaemia (blood glucose ≤3.9 mmol/l) after insulin injection;
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participants will be followed for the duration of the study, an expected average of 4 weeks
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exogenous glucose
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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Amount of exogenous glucose required to prevent hypoglycaemia after insulin injection
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participants will be followed for the duration of the study, an expected average of 4 weeks
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time exogenous glucose requirement
Time Frame: participants will be followed for the duration of the study, an expected average of 4 weeks
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Duration of time that exogenous glucose is required to prevent hypoglycaemia after insulin injection.
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participants will be followed for the duration of the study, an expected average of 4 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Bastiaan de Galan, MD PhD, Radboud University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKPD_INSJ_3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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