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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insujet is tested first | Other | first procedure: experiment with the investigational product (Insujet pen)containing insulin aspart; second procedure: control device (conventional Novopen III insulin pen) contains insulin aspart. |
|
| insujet is tested second | Other | first procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| T-BG≥10 | the time in minutes until plasma glucose concentration has dropped with ≥ 10mmol/l (T-BG≥10). | participants will be followed for the duration of the study, an expected average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| T-BG5 and 8 (min) | the time in minutes until plasma glucose values drop below 8 an 5 mmol/l, respectively | participants will be followed for the duration of the study, an expected average of 4 weeks |
| Rfall |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain | 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) | participants will be followed for the duration of the study, an expected average of 4 weeks |
| hypoglycaemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bastiaan de Galan, MD PhD | Radboud University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | 6500HB | Netherlands |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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the slope of the glucose fall (mmol • l-1 • min-1), calculated from the time- glucose curve
| participants will be followed for the duration of the study, an expected average of 4 weeks |
| BG-AUC 0-2h | the area under the time-glucose curve, reflecting post-injection hyperglycaemic burden, from 0 to 2h after insulin injection. | participants will be followed for the duration of the study, an expected average of 4 weeks |
| BG-AUC 0-6h | the area under the time-glucose curve (mmol • min-1 • l-1), from 0 to 6h after insulin injection. | participants will be followed for the duration of the study, an expected average of 4 weeks |
| C-INSmax (pmol/l) | maximal insulin concentration | participants will be followed for the duration of the study, an expected average of 4 weeks |
| T-INSmax | time to maximal insulin concentration in minutes(C-INSmax) | participants will be followed for the duration of the study, an expected average of 4 weeks |
| T-INSBL | the time until plasma insulin values drop below baseline values (minutes) | participants will be followed for the duration of the study, an expected average of 4 weeks |
| INSAUC | area under the insulin concentration curve (pmol • min-1 • l-1)(from timepoint 0), reflects total insulin absorption | participants will be followed for the duration of the study, an expected average of 4 weeks |
| T-INSAUC50% | time until 50% of insulin absorption in minutes(mean residence time, MRT) | participants will be followed for the duration of the study, an expected average of 4 weeks |
Number of patients requiring exogenous glucose infusion to prevent hypoglycaemia (blood glucose ≤3.9 mmol/l) after insulin injection; |
| participants will be followed for the duration of the study, an expected average of 4 weeks |
| exogenous glucose | Amount of exogenous glucose required to prevent hypoglycaemia after insulin injection | participants will be followed for the duration of the study, an expected average of 4 weeks |
| time exogenous glucose requirement | Duration of time that exogenous glucose is required to prevent hypoglycaemia after insulin injection. | participants will be followed for the duration of the study, an expected average of 4 weeks |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |