Diabetes MellitusNCT01947556
Insulin by Jet-injection for Hyperglycemia in Diabetes
A study testing insulin aspart in people with Diabetes Mellitus, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
Official title: The Effect of Rapid-acting Insulin Injected by Needle-free Jet-injection in the Management of Hyperglycemia in Patients With Diabetes
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
Read the 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
- Being tested
- insulin aspart
- Keywords
- diabetes, insulin administration, hyperglycaemia, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Also called Novorapid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 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. Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-BG≥10
the time in minutes until plasma glucose concentration has dropped with ≥ 10mmol/l (T-BG≥10).
Measured: participants will be followed for the duration of the study, an expected average of 4 weeks
Secondary outcomes (9)
T-BG5 and 8 (min)
the time in minutes until plasma glucose values drop below 8 an 5 mmol/l, respectively
Measured: participants will be followed for the duration of the study, an expected average of 4 weeks
Rfall
the slope of the glucose fall (mmol • l-1 • min-1), calculated from the time- glucose curve
Measured: 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.
Measured: 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.
Measured: participants will be followed for the duration of the study, an expected average of 4 weeks
C-INSmax (pmol/l)
maximal insulin concentration
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: participants will be followed for the duration of the study, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HM de Wit, University Medical Center Nijmegen
- Investigators
- Bastiaan de Galan, MD PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947556
- Sponsor's protocol ID
- PKPD_INSJ_3
- Status last verified
- Nov 2014
- First submitted
- 2 Sep 2013
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rapid-acting Insulin Injected by Needle-free Jet-injection in the Management of Hyperglycemia in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01947556
- Acronym / sponsor ID
- PKPD_INSJ_3
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, insulin administration, hyperglycaemia, insulin aspart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insujet is tested first | Other | Drug: insulin aspartfirst 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 | Drug: insulin aspartfirst procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin aspartAlso: NovorapidAfter 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. | Drug | insujet is tested first, insujet is tested second |
Primary outcome
T-BG≥10
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 concentration has dropped with ≥ 10mmol/l (T-BG≥10).
9 secondary outcomes
T-BG5 and 8 (min)
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
Rfall
Time frame: 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
BG-AUC 0-6h
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
C-INSmax (pmol/l)
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
T-INSmax
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
T-INSBL
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
INSAUC
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
T-INSAUC50%
Time frame: participants will be followed for the duration of the study, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bastiaan de Galan, MD PhD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin aspart in people with Diabetes Mellitus, run by University Medical Center Nijmegen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-BG≥10 (time frame: participants will be followed for the duration of the study, an expected average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.