Diabetes Mellitus, Type 1Phase 2NCT00553488
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
A Phase 2 study testing Regular insulin (Humulin) and Insulin lispro (Humalog) in people with Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 1 site in Germany.
Trial summary
This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously, for control or comparison purposes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Regular insulin (Humulin) and Insulin lispro (Humalog)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jan 2008
- Phase
- Phase 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c <= 9.0%.
- Able to attend clinic for 5 different days
Who cannot join
- BMI > 32 kg/m2
- Evidence of gastroparesis or impaired renal function or lipodystrophy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mono Center Open Labeled, Randomized Study Examining the Effects of Intra-Dermal vs Subcutaneous Application of Regular Insulin or Rapid Acting Insulin Analogue on Postprandial Glycemic Excursions in Patients With Type 1 Diabetes
This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously, for control or comparison purposes. The hypothesis or expectation is that ID insulin will work more quickly and control blood glucose levels better than SC injection.
Read the detailed description
Previous studies have shown that intra-dermal (ID) insulin administration results in a more rapid onset of action in comparison to subcutaneous (SC) administration as measured by glucose infusion rate (GIR) under glucose clamp conditions.The aim of this study is to investigate whether ID administration of regular human insulin or rapid-acting insulin analogue leads to reduced postprandial glycemic excursions in comparison to SC application under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia will also be investigated, as well as pK and pD comparisons between different insulin formulations administered ID. This is a mono-center, open-label, randomized, 5-period crossover study in patients with type 1 diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Regular insulin (Humulin), Insulin lispro (Humalog)
- Keywords
- diabetes, insulin, subcutaneous, intra-dermal, blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular insulin (Humulin)Drug
Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
Insulin lispro (Humalog)Drug
Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Regular insulin SC at -17 mins Receives: Drug: Regular insulin (Humulin) |
| 2 | Active comparator | Regular insulin ID at -17 mins Receives: Drug: Regular insulin (Humulin) |
| 3 | Active comparator | Regular insulin ID at -2 mins Receives: Drug: Regular insulin (Humulin) |
| 4 | Active comparator | Insulin lispro given SC at -2 mins Receives: Drug: Insulin lispro (Humalog) |
| 5 | Experimental | Insulin lispro given ID at -2 mins Receives: Drug: Insulin lispro (Humalog) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
Measured: 90 mins
Secondary outcomes (7)
Maximal BG (BGmax)
Measured: Approximately 4 hours per injection
Total BG-AUC0-4 h
Measured: Approximately 4 hrs per injection
Minimal BG (BGmin, time to BGmin (tBGmin)
Measured: Approximately 4 hrs per injection
Insulin pharmacokinetics
Measured: Approximately 4 hrs per injection
Number and seriousness of adverse events
Measured: Approximately 4 hrs per injections
Vital signs, examination of insulin application
Measured: Approximately 4 hrs per injection
Time to BGmax (tBGmax)
Measured: Approximately 4 hours per injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Kapitza, MD, Principal investigator, Profil Institut fur Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553488
- Sponsor's protocol ID
- BDT-ADD-07-002
- Other IDs
- EudraCT number 2007-003924-39
- Status last verified
- Aug 2008
- First submitted
- 12 Oct 2007
- Last updated
- 22 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Pettis RJ, Hirsch L, Kapitza C, Nosek L, Hovelmann U, Kurth HJ, Sutter DE, Harvey NG, Heinemann L. Microneedle-based intradermal versus subcutaneous administration of regular human insulin or insulin lispro: pharmacokinetics and postprandial glycemic excursions in patients with type 1 diabetes. Diabetes Technol Ther. 2011 Apr;13(4):443-50. doi: 10.1089/dia.2010.0183. Epub 2011 Feb 28.
PubMed 21355716
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mono Center Open Labeled, Randomized Study Examining the Effects of Intra-Dermal vs Subcutaneous Application of Regular Insulin or Rapid Acting Insulin Analogue on Postprandial Glycemic Excursions in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00553488
- Acronym / sponsor ID
- BDT-ADD-07-002
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes, insulin, subcutaneous, intra-dermal, blood glucose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 5 Nov 2007 (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.
This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously, for control or comparison purposes. The hypothesis or expectation is that ID insulin will work more quickly and control blood glucose levels better than SC injection.
Detailed description
Previous studies have shown that intra-dermal (ID) insulin administration results in a more rapid onset of action in comparison to subcutaneous (SC) administration as measured by glucose infusion rate (GIR) under glucose clamp conditions.The aim of this study is to investigate whether ID administration of regular human insulin or rapid-acting insulin analogue leads to reduced postprandial glycemic excursions in comparison to SC application under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia will also be investigated, as well as pK and pD comparisons between different insulin formulations administered ID. This is a mono-center, open-label, randomized, 5-period crossover study in patients with type 1 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Regular insulin (Humulin)Regular insulin SC at -17 mins |
| 2 | Active comparator | Drug: Regular insulin (Humulin)Regular insulin ID at -17 mins |
| 3 | Active comparator | Drug: Regular insulin (Humulin)Regular insulin ID at -2 mins |
| 4 | Active comparator | Drug: Insulin lispro (Humalog)Insulin lispro given SC at -2 mins |
| 5 | Experimental | Drug: Insulin lispro (Humalog)Insulin lispro given ID at -2 mins |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c <= 9.0%.
- Able to attend clinic for 5 different days
Key exclusion criteria (2 listed)
- BMI > 32 kg/m2
- Evidence of gastroparesis or impaired renal function or lipodystrophy
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 |
|---|---|---|
| Regular insulin (Humulin)Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days. | Drug | 1, 2, 3 |
| Insulin lispro (Humalog)Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days. | Drug | 4, 5 |
Primary outcome
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
Time frame: 90 mins
7 secondary outcomes
Maximal BG (BGmax)
Time frame: Approximately 4 hours per injection
Total BG-AUC0-4 h
Time frame: Approximately 4 hrs per injection
Minimal BG (BGmin, time to BGmin (tBGmin)
Time frame: Approximately 4 hrs per injection
Insulin pharmacokinetics
Time frame: Approximately 4 hrs per injection
Number and seriousness of adverse events
Time frame: Approximately 4 hrs per injections
Vital signs, examination of insulin application
Time frame: Approximately 4 hrs per injection
Time to BGmax (tBGmax)
Time frame: Approximately 4 hours per injection
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 22 Aug 2008.
- Derived from this study: PubMed 21355716Pettis RJ, Hirsch L, Kapitza C, Nosek L, Hovelmann U, Kurth HJ, Sutter DE, Harvey NG, Heinemann L. Microneedle-based intradermal versus subcutaneous administration of regular human insulin or insulin lispro: pharmacokinetics and postprandial glycemic excursions in patients with type 1 diabetes. Diabetes Technol Ther. 2011 Apr;13(4):443-50. doi: 10.1089/dia.2010.0183. Epub 2011 Feb 28.
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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 Institut fur Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regular insulin (Humulin) and Insulin lispro (Humalog) in people with Diabetes Mellitus, Type 1, 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 2 inclusion and 2 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 22 Aug 2008. 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 phase mean?
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?
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. (time frame: 90 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553488, which also lists 1 linked publication.
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 22 Aug 2008.