- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025513
De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy
March 19, 2024 updated by: Neodyne Biosciences, Inc.
A Phase 1 Study to Assess the Safety and Efficacy of Embrace, De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy (LH)
This is a single-center, single-cohort, open, repeated-application study.
Baseline assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with pre-meal insulin injected into the LH lesion.
Subjects will discontinue their basal insulin for 2-3 days after the Continuous glucose monitor (CGM) study ends, prior to admission to the research center ("wash-out").
After release from the research center, subjects will wear the Embrace over the target LH lesion for 16 weeks.
At the beginning of week 17, the clamp and MMTT will be repeated, after which participants will again wear an unblinded CGM for ~6 days with injections only in the target LH lesion when applying an Embrace patch with a hole.
A needle biopsy will be taken from the LH lesion at baseline and again at study completion.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, single-cohort, open, repeated-application study.
Baseline assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with pre-meal insulin injected into the LH lesion.
However, before admission to the research center, unblinded CGM is worn for ~13 days (day 1 is discarded to avoid variability, day 2-7 bolus injections in Normal Tissue (NAT) and day 8-13 bolus injections in target LH) as outpatients.
Subjects will discontinue their basal insulin for 2-3 days after the CGM study ends, prior to admission to the research center ("wash-out").
After release from the research center, subjects will wear the Embrace over the target LH lesion for 16 weeks, reapplying the patch every week and avoiding any injections in the target LH lesion.
Basal insulin is injected only in NAT away from the LH site.
At the beginning of week 17, the clamp and MMTT will be repeated, after which participants will again wear an unblinded CGM for ~6 days (again, day 1 is discarded) with injections only in the target LH lesion when applying an Embrace patch with a hole.
A needle biopsy will be taken from the LH lesion at baseline and again at study completion.
Study Type
Interventional
Enrollment (Estimated)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jasper Jackson
- Phone Number: 1-800-519-7127
- Email: jjackson@neodynebio.com
Study Locations
-
-
-
Neuss, Germany
- Recruiting
- Profil
-
Contact:
- Steve Michel
- Phone Number: +49(0)21314018419
- Email: steve.michel@profil.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.
- Subject with type 1 diabetes for at least 3 years
- One or more palpable lipohypertrophy lesions in the abdominal area, the largest of which has a minimum size of 3.0 cm and a maximum size of 12.0 cm (longest axis) as confirmed by ultrasound.
- Treated with multiple daily injections (≥3) of insulin for at least 2 years or continuous subcutaneous insulin infusion for at least 1 year.
- Subject is willing and able to continue same basal insulin during trial participation.
- Body Mass Index (BMI) 18.5 to 30.0 kg/m², inclusive
- HbA1c at screening between 6.5% and 9.5% (inclusive)
- Have clinical laboratory test results within the normal range for the population, or with abnormalities deemed clinically insignificant by the investigator.
- Considered generally healthy (apart from type 1 diabetes and lipohypertrophy) upon completion of medical history and screening safety assessments, as judged by the Investigator
- Have venous access sufficient to allow cannulation for blood sampling as required by the protocol
Exclusion Criteria:
- Receipt of any medicinal product in clinical development within 60 days or 5 half-lives (if known) of the medicinal product before randomisation in this trial
- Any history or presence of cancer, except for a history of basal cell skin cancer or squamous cell skin cancer (as judged by the Investigator)
- Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator.
- Signs of acute illness as judged by the Investigator
- Any serious systemic infectious disease during four weeks prior to screening, as judged by the Investigator.
- Aspartate transaminase (AST) and/or Alanine transaminase (ALT) > 2 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR)<60 mL/min
- Systolic blood pressure < 90 mmHg or >160 mmHg and/or diastolic blood pressure < 50 mmHg or > 95 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
- Heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
- History of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months
- Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day (for males), 12 grams alcohol/day (for females) on average
- A positive result in the alcohol and/or urine drug screen at the screening visit
- Tested positive for Hepatitis Bs antigen
- Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal, and a hepatitis C polymerase chain reaction is negative)
- Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
- Have received chronic (lasting >14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) in the past 3 months, or have received any non-topical glucocorticoid therapy within 30 days before screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: embrace patch treatment
Insulin PK/PD before and after treatment with embrace patch
|
Tension offloading skin patch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin
Time Frame: 16 weeks
|
Area under the glucose infusion rate curve (AUCGIR),0-4h: area under the glucose infusion rate curve from 0 to 4 hrs after injection of a 0.15 units/kg body weight dose of insulin lispro
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc Stoffel, Doctor, Profil Institut für Stoffwechselforschung GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
August 23, 2023
First Submitted That Met QC Criteria
August 29, 2023
First Posted (Actual)
September 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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