DiabetesPhase 1/2NCT01120444
Study on the Effects on Blood Glucose Following Intradermal and Subcutaneous Dosing of Insulin in Diabetic Patients
A Phase 1/2 study testing BD Research Catheter with 34G x 1.5 mm needle and Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set in people with Diabetes, run by Becton, Dickinson and Company at 1 site in Germany.
Trial summary
The purpose of this study is to compare the effects of bolus delivery of insulin when delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes
- What is being tested?
- BD Research Catheter with 34G x 1.5 mm needle and Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients will be included in the trial only if they fulfill all of the inclusion criteria mentioned below:
- Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)
- Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year.
- Usage of insulin pump therapy or multiple daily injections ("basal-bolus") with carb counting for at least six months
- Age in the range of ≥18 and ≤55 years
- Body mass index (BMI) ≤32 kg/m²
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- HbA1c ≤ 8.0% at screening
- Able and willing to adhere to the study procedures for the entire trial period
- Negative test results for hepatitis C antibodies, hepatitis B surface antigen and HIV at screening.
Who cannot join
- Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:
- Previous participation in this trial or participation in a clinical trial within 3 months prior to screening examination
- Any symptoms suggestive of, or a diagnosis or treatment for gastroparesis
- Abnormalities in renal function (e.g. serum creatinine >1.2 mg/dl) or judged by the investigator that would pose a problem of clearance of injected insulin
- Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
- Acute and severe illness apart from diabetes mellitus as judged by the investigator
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- Abnormalities in the laboratory parameters if judged as clinically significant by the investigator. In particular, patients with GOT/GPT >3x, thrombocyte count <100/nL, INR >1.3, PTT >50 sec.
- Clinically significant abnormalities in the ECG
- Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator
- Lipodystrophy which in the judgment of the investigator would pose a problem in terms of variability of absorption of injected insulin
- Use of systemic corticoids for the last three month prior screening examination or treatment with medication known to interfere with glucose metabolism such as non-selective ß-blockers, or mono amine oxidase (MAO) inhibitors, ACE-inhibitors or thiazides, unless such medical treatment has existed for at least three months and is not changing, prior to screening examination
- Any disease requiring use of anti-coagulants
- Impaired hepatic or renal functions as judged by the investigator Cardiac problems as judged by the investigator
- Uncontrolled hypertension (treated or untreated) as judged by the investigator (RRsyst. >140 mmHg, RRdiast. > 90 mmHg)
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation Current addiction to alcohol or substances of abuse as determined by the investigator
- Allergy to plaster/adhesive
- Any other condition that the investigator feels would interfere with trial participation or evaluation of results.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Randomized Study Examining the Glycemic Effects of ID vs SC Bolus Dosing of Insulin Lispro in Patients With Type 1 Diabetes
The purpose of this study is to compare the effects of bolus delivery of insulin when delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.
Read the detailed description
Each patient will participate in 10 visits of which the first, Visit 1, is a Screening Visit.
Visit 2 will consist of a brief isoglycemic clamp with a single IV insulin challenge to determine insulin sensitivity. A subsequent test meal and single SC insulin dose (off clamp) will be done to determine the nominal coverage dose of insulin for a mixed meal containing 60g of carbohydrate. This nominal dose will form the basis of insulin bolus dosing for the remainder of the study visits.
For Visits 3-9, patients will come to the institute in the early morning 24 hours prior to the meal test for the application of a Continuous Glucose Monitor (Dexcom Seven Plus™, Dexcom, INC). Subjects will receive standardized meals during the day and their blood glucose will be stabilized overnight to a concentration of 115±15 mg/dL via IV insulin and/or glucose infusions. The next morning the subjects will start the experimental intervention. Immediately prior to standardized meals (2 minutes before eating) the patients will receive insulin by either the ID or SC route, followed by the breakfast (rapidly absorbed carb) meal at time point T0. Meal consumption will occur over a 10 to 15 min time interval. Blood glucose excursions will be observed in the 6 hours thereafter (until T= 360 min). Between hours 6 to 7, BG may be re-stabilized to starting values (115±15 mg/dL) by administration of IV insulin or glucose if necessary. At that time a second insulin injection (same dose as at time point T= -2 minutes) will be given and a second standardized lunch (mixed) meal will be administered. Blood glucose excursions will be followed for an additional 6 hours thereafter (T = 780 minutes)
Conditions for Visits 3-8 will be:
- Condition 1. Individualized Lispro ID dose (nominal dose based on prior insulin sensitivity testing and patient-specific insulin-to-carb ratio) given immediately (2min) prior to a breakfast meal containing predominantly rapidly absorbed carbohydrates (std 60 g CHO; approximately 70:15:15 CHO:protein:fat); a second lunch mixed meal given 7 hours later contains the same total number of carbohydrates (std 60 g mixed) but with a mixed composition between carbohydrate, protein, and fat (ratio approximately 35:25:40).
- Condition 2. Equivalent insulin dose and meal regimen as Condition 1 but given by the SC route.
- Conditions 3 and 4. The meal regimen from Condition 1, with ID and SC doses increased 30% above the nominal dose to simulate inappropriate carb counting.
- Conditions 5 and 6. The meal regimen from Condition 1, with ID and SC doses decreased 30% below the nominal dose to simulate inappropriate carb counting.
In addition during each meal challenge the subject will be maintained on an Animas pump intradermally delivering a combined bolus and basal profile of a placebo (5% dextrose for injection solution) during the study period to evaluate flow biomechanics.
Visit 9 will examine a single earlier dose timing (determined by analysis of the glycemic profile dataset from the prior 8 visits) relative to the two meals for the ID route only, using the optimal target dose from conditions 1 and 2.
Patients will have a final examination, Visit 10, immediately following Visit 9.
- Conditions
- Diabetes
- Being tested
- BD Research Catheter with 34G x 1.5 mm needle, Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set
- Keywords
- Diabetes, Insulin, Blood Glucose
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Research Catheter with 34G x 1.5 mm needleDevice
bolus injection of insulin given intradermal prior to standardized meal
Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion setDevice
Also called Disetronic Accu-Chek Rapid D infusion set - 6mm cannula
bolus delivery of insulin given subcutaneously prior to standardized meal
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous delivery of insulin | Active comparator | A bolus dose of insulin will be given subcutaneously just prior to a standardized meal. Receives: Device: Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set |
| Intradermal delivery of insulin | Experimental | A bolus dose of insulin will be given intradermally just prior to a standardized meal Receives: Device: BD Research Catheter with 34G x 1.5 mm needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
To compare between the ID and SC routes the relative PD times "in-range" (70-180 mg/dL) for glycemic excursions following two types of standardized meals and three dose ranges (optimum dose and +/- 30%).
Measured: 12-14 hours
Secondary outcomes (1)
Insulin levels
To compare the pharmacokinetics of insulin absorption as well as the intra-subject variability for each delivery routes.
Measured: 12-14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Kapitza, MD, Principal investigator, Profil Institute of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120444
- Sponsor's protocol ID
- BDT-09-ADC004
- Status last verified
- Apr 2011
- First submitted
- 7 May 2010
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Randomized Study Examining the Glycemic Effects of ID vs SC Bolus Dosing of Insulin Lispro in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01120444
- Acronym / sponsor ID
- BDT-09-ADC004
- Conditions
- Diabetes
- Keywords
- Diabetes, Insulin, Blood Glucose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 May 2010 (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 effects of bolus delivery of insulin when delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.
Detailed description
Each patient will participate in 10 visits of which the first, Visit 1, is a Screening Visit.
Visit 2 will consist of a brief isoglycemic clamp with a single IV insulin challenge to determine insulin sensitivity. A subsequent test meal and single SC insulin dose (off clamp) will be done to determine the nominal coverage dose of insulin for a mixed meal containing 60g of carbohydrate. This nominal dose will form the basis of insulin bolus dosing for the remainder of the study visits.
For Visits 3-9, patients will come to the institute in the early morning 24 hours prior to the meal test for the application of a Continuous Glucose Monitor (Dexcom Seven Plus™, Dexcom, INC). Subjects will receive standardized meals during the day and their blood glucose will be stabilized overnight to a concentration of 115±15 mg/dL via IV insulin and/or glucose infusions. The next morning the subjects will start the experimental intervention. Immediately prior to standardized meals (2 minutes before eating) the patients will receive insulin by either the ID or SC route, followed by the breakfast (rapidly absorbed carb) meal at time point T0. Meal consumption will occur over a 10 to 15 min time interval. Blood glucose excursions will be observed in the 6 hours thereafter (until T= 360 min). Between hours 6 to 7, BG may be re-stabilized to starting values (115±15 mg/dL) by administration of IV insulin or glucose if necessary. At that time a second insulin injection (same dose as at time point T= -2 minutes) will be given and a second standardized lunch (mixed) meal will be administered. Blood glucose excursions will be followed for an additional 6 hours thereafter (T = 780 minutes)
Conditions for Visits 3-8 will be:
- Condition 1. Individualized Lispro ID dose (nominal dose based on prior insulin sensitivity testing and patient-specific insulin-to-carb ratio) given immediately (2min) prior to a breakfast meal containing predominantly rapidly absorbed carbohydrates (std 60 g CHO; approximately 70:15:15 CHO:protein:fat); a second lunch mixed meal given 7 hours later contains the same total number of carbohydrates (std 60 g mixed) but with a mixed composition between carbohydrate, protein, and fat (ratio approximately 35:25:40).
- Condition 2. Equivalent insulin dose and meal regimen as Condition 1 but given by the SC route.
- Conditions 3 and 4. The meal regimen from Condition 1, with ID and SC doses increased 30% above the nominal dose to simulate inappropriate carb counting.
- Conditions 5 and 6. The meal regimen from Condition 1, with ID and SC doses decreased 30% below the nominal dose to simulate inappropriate carb counting.
In addition during each meal challenge the subject will be maintained on an Animas pump intradermally delivering a combined bolus and basal profile of a placebo (5% dextrose for injection solution) during the study period to evaluate flow biomechanics.
Visit 9 will examine a single earlier dose timing (determined by analysis of the glycemic profile dataset from the prior 8 visits) relative to the two meals for the ID route only, using the optimal target dose from conditions 1 and 2.
Patients will have a final examination, Visit 10, immediately following Visit 9.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous delivery of insulin | Active comparator | Device: Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion setA bolus dose of insulin will be given subcutaneously just prior to a standardized meal. |
| Intradermal delivery of insulin | Experimental | Device: BD Research Catheter with 34G x 1.5 mm needleA bolus dose of insulin will be given intradermally just prior to a standardized meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female patients will be included in the trial only if they fulfill all of the inclusion criteria mentioned below:
- Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)
- Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year.
- Usage of insulin pump therapy or multiple daily injections ("basal-bolus") with carb counting for at least six months
- Age in the range of ≥18 and ≤55 years
Key exclusion criteria (18 listed)
- Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:
- Previous participation in this trial or participation in a clinical trial within 3 months prior to screening examination
- Any symptoms suggestive of, or a diagnosis or treatment for gastroparesis
- Abnormalities in renal function (e.g. serum creatinine >1.2 mg/dl) or judged by the investigator that would pose a problem of clearance of injected insulin
- Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
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 |
|---|---|---|
| BD Research Catheter with 34G x 1.5 mm needlebolus injection of insulin given intradermal prior to standardized meal | Device | Intradermal delivery of insulin |
| Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion setAlso: Disetronic Accu-Chek Rapid D infusion set - 6mm cannulabolus delivery of insulin given subcutaneously prior to standardized meal | Device | Subcutaneous delivery of insulin |
Primary outcome
Blood Glucose
Time frame: 12-14 hours
To compare between the ID and SC routes the relative PD times "in-range" (70-180 mg/dL) for glycemic excursions following two types of standardized meals and three dose ranges (optimum dose and +/- 30%).
1 secondary outcome
Insulin levels
Time frame: 12-14 hours
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 18 Apr 2011.
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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.
Christoph Kapitza, MD principal investigator
Profil Institute of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BD Research Catheter with 34G x 1.5 mm needle and Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set in people with Diabetes, run by Becton, Dickinson and Company at 1 site in Germany.
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 9 inclusion and 18 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 18 Apr 2011. 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 Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood Glucose (time frame: 12-14 hours). 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 18 Apr 2011.