Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01947556
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2013-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Insulin by Jet-injection for Hyperglycemia in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'NRS pain', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': '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)'}, {'measure': 'hypoglycaemia', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'Number of patients requiring exogenous glucose infusion to prevent hypoglycaemia (blood glucose ≤3.9 mmol/l) after insulin injection;'}, {'measure': 'exogenous glucose', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'Amount of exogenous glucose required to prevent hypoglycaemia after insulin injection'}, {'measure': 'time exogenous glucose requirement', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'Duration of time that exogenous glucose is required to prevent hypoglycaemia after insulin injection.'}], 'primaryOutcomes': [{'measure': 'T-BG≥10', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'the time in minutes until plasma glucose concentration has dropped with ≥ 10mmol/l (T-BG≥10).'}], 'secondaryOutcomes': [{'measure': 'T-BG5 and 8 (min)', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'the time in minutes until plasma glucose values drop below 8 an 5 mmol/l, respectively'}, {'measure': 'Rfall', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'the slope of the glucose fall (mmol • l-1 • min-1), calculated from the time- glucose curve'}, {'measure': 'BG-AUC 0-2h', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'the area under the time-glucose curve, reflecting post-injection hyperglycaemic burden, from 0 to 2h after insulin injection.'}, {'measure': 'BG-AUC 0-6h', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'the area under the time-glucose curve (mmol • min-1 • l-1), from 0 to 6h after insulin injection.'}, {'measure': 'C-INSmax (pmol/l)', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'maximal insulin concentration'}, {'measure': 'T-INSmax', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'time to maximal insulin concentration in minutes(C-INSmax)'}, {'measure': 'T-INSBL', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'the time until plasma insulin values drop below baseline values (minutes)'}, {'measure': 'INSAUC', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'area under the insulin concentration curve (pmol • min-1 • l-1)(from timepoint 0), reflects total insulin absorption'}, {'measure': 'T-INSAUC50%', 'timeFrame': 'participants will be followed for the duration of the study, an expected average of 4 weeks', 'description': 'time until 50% of insulin absorption in minutes(mean residence time, MRT)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'insulin administration', 'hyperglycaemia', 'insulin aspart'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nTo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes mellitus type 1 or 2\n* Age 18-75 years\n* Body-Mass Index ≥25 kg/m2 and ≤40 kg/m2\n* Stable glycaemic control with HbA1c ≥48 (6.5%) and ≤86 mmol/mol (10%)\n* 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\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Insulin requirement of \\<34 or \\>200 units per day\n* Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs\n* Known allergy to aspart insulin\n* Use of oral antidiabetic drugs other than metformin\n* Symptomatic diabetic neuropathy\n* 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\n* Pregnancy or the intention to become pregnant\n* Renal disease (creatinine \\>150 μmol/l or MDRD-GFR \\<30 ml/min/1.73m2)\n* Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)\n* Presence of any other medical condition that might interfere with the study protocol\n* anemia'}, 'identificationModule': {'nctId': 'NCT01947556', 'briefTitle': 'Insulin by Jet-injection for Hyperglycemia in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Nijmegen'}, 'officialTitle': 'The Effect of Rapid-acting Insulin Injected by Needle-free Jet-injection in the Management of Hyperglycemia in Patients With Diabetes', 'orgStudyIdInfo': {'id': 'PKPD_INSJ_3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'insujet is tested first', 'description': 'first procedure: experiment with the investigational product (Insujet pen)containing insulin aspart; second procedure: control device (conventional Novopen III insulin pen) contains insulin aspart.', 'interventionNames': ['Drug: insulin aspart']}, {'type': 'OTHER', 'label': 'insujet is tested second', 'description': 'first procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart.', 'interventionNames': ['Drug: insulin aspart']}], 'interventions': [{'name': 'insulin aspart', 'type': 'DRUG', 'otherNames': ['Novorapid'], 'description': '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.', 'armGroupLabels': ['insujet is tested first', 'insujet is tested second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Bastiaan de Galan, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Nijmegen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'HM de Wit', 'investigatorAffiliation': 'University Medical Center Nijmegen'}}}}