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Diabetes Mellitus, Type 1Phase 1/2NCT01061216

Pharmacokinetics/Dynamics of Basal (Continuous) Insulin Infusion Administered Either Intradermally or Subcutaneously

A Phase 1/2 study testing Intradermal insulin delivery: BD Research Catheter Set and Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study will be to assess the PK/PD responsiveness of basal ID administered insulin compared to SC, and to determine the safety and local tolerability of extended (two six-hour periods) microneedle insulin delivery (MID) infusion. Read more about this study

Who is it for?
Ages 18 to 55 years, men only
What is being tested?
Intradermal insulin delivery: BD Research Catheter Set and Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
Jan 2010to Mar 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
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 subject)
  • Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year
  • Current treatment:Insulin Pump
  • Age in the range of greater than or equal to 18 and less than or equal to 55 years
  • Body mass index (BMI) less than or equal to 32 kg/m²
  • HbA1c less than or equal to 9.0 %
  • 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

  • Previous participation in this trial or participation in a clinical trial within 3 months prior 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
  • Abnormalities in the laboratory parameters if judged as clinically significant by the investigator. In particular, subjects with GOT/GPT >3x, thrombocyte count <100/nL, INR >1.3, PTT >50 sec. will not be permitted to enter the study.
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  • 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 months prior to 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 medical treatment having existed for at least three month prior 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.
  • Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
  • Subjects with a history of deep leg vein thrombosis or with frequent appearance of deep leg vein thrombosis in 1st degree relatives as judged by the investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, D-41460

Other trials in Germany

About this study

Official title: A Mono-center, Open Label, Randomised 2-period Crossover Study to Compare the Pharmacokinetics and Pharmacodynamics of Continuous Insulin Infusion Administered Either Intradermally or Subcutaneously in Subjects With Type 1 Diabetes Mellitus

The primary objective of this study will be to assess the PK/PD responsiveness of basal ID administered insulin compared to SC, and to determine the safety and local tolerability of extended (two six-hour periods) microneedle insulin delivery (MID) infusion. The primary endpoint will be the PK response to changes in rapid-acting insulin basal infusion rate.

Faster PK transitions coupled with faster PD responsiveness could provide clinical benefit, compared to current subcutaneous insulin infusion. In addition, for nocturnal basal pumping, more rapid insulin offset could decrease the occurrence rate and severity of hypoglycemic episodes.

Read the detailed description

Twenty (20) male T1 diabetic subjects will be studied under manual partial glucose clamp conditions over a 16 hour infusion period (approximately 36 hours of overall time in clinic). Subjects will be admitted to the clinic the night before their study visit for overnight stabilization in which, via insulin and/or glucose infusions, blood glucose will be stabilized to approximately 140 mg/dL. Subjects will receive as background IV Humulin insulin with an initial dose equivalent to one-half of their usual daily basal insulin dose. In the morning the subjects will start the experimental intervention and have administered a low rate stair-stepped Lispro insulin infusion profile via an infusion pump (Harvard Syringe Pump, Harvard Apparatus).

The profile is designed to examine the initial "on" rate for microneedle insulin delivery, the transition time between basal rate changes and the "off-rate" after insulin cessation. Subjects will receive the same profile by SC infusion on a second clinic day in a randomized order. PK endpoints will be established using timed blood samples. Safety and tolerability at the local infusion site will also be recorded.

In parallel, using a commercially available insulin pump (One Touch "Ping" Insulin Pump, Animas) and an infusion set (either the RCS or a commercially available SC insulin infusion set); a second infusion of insulin diluent will be used to assess the feasibility of longer-term ID infusions (16 hours) as compared to SC.

During each infusion the pumps will control the fluid delivery rate and volume. In addition an in-line pressure transducer will record the pressure and transfer the information to a laptop computer.

Primary Objective:

  • To define the PK profile of initiation, rate change, and discontinuation of continuously infused basal insulin administered either intradermally or subcutaneously over two separate infusion periods.

Secondary Objectives:

  • Determine the PD effect of the infused insulin as measured by time to glucose rebound following discontinuation of test insulin infusion.
  • Assess the safety and tolerability of intradermally infused insulin over two six-hour periods.
  • Assess the feasibility of the research catheter set (RCS) for longer-term ID infusion
Being tested
Intradermal insulin delivery: BD Research Catheter Set, Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set
Keywords
Diabetes, Insulin Therapy, Blood Glucose, Basal insulin, Diabetics
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intradermal insulin delivery: BD Research Catheter SetDevice

    1 unit/hr rapid acting insulin delivered intradermally for 6 hours 4 hour washout period (no insulin delivered) 2 units/hr rapid acting insulin delivered intradermally for 6 hours 4 hour washout period (no insulin delivered)

  • Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion SetDevice

    Also called ACCU-CHEK, Rapid-D Infusion Set (Disetronic, USA)

    1 unit per hour of rapid acting insulin infusion for 6 hours 4 hour washout (no insulin delivered) 2 unit per hour of rapid acting insulin infusion for 6 hours 4 hour washout (no insulin delivered)

Study groups in NCT01061216
Study groupRoleWhat they receive
Intradermal insulin infusion (ID)ExperimentalNot described
Receives: Device: Intradermal insulin delivery: BD Research Catheter Set
Subcutaneous insulin infusion (SC)Active comparatorNot described
Receives: Device: Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin measurements will be used to compute PK model parameters: absorption rate(s) and elimination rate using an appropriate transport model.

    Measured: 20 hours

Secondary outcomes (3)

  1. Pharmacodynamic glycemic parameters will be as follows: time from insulin infusion onset to glycemic nadir; time from test insulin shutoff to return to baseline glucose; amount of additional drop in blood glucose following test insulin infusion shutoff

    Measured: 20 hours

  2. Evidence of safety and tolerability of intradermally infused insulin

    Measured: 26 hours

  3. Feasibility of RCS for longer-term ID infusion

    Measured: 16 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061216
Sponsor's protocol ID
BDT-09-ADC003
Other IDs
2009-016164-36, 2009
Status last verified
Mar 2010
First submitted
29 Jan 2010
Last updated
10 Mar 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intradermal insulin delivery: BD Research Catheter Set and Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, 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 8 inclusion and 20 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 10 Mar 2010. 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?

Insulin measurements will be used to compute PK model parameters: absorption rate(s) and elimination rate using an appropriate transport model. (time frame: 20 hours). 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 NCT01061216.

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 10 Mar 2010.

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