Insulin ResistanceNCT06025513
De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy
A study testing Embrace Patch in people with Insulin Resistance and Lipohypertrophy, run by Neodyne Biosciences, Inc. at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Lipohypertrophy
- What is being tested?
- Embrace Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- 16 Feb 2024to 13 Mar 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Insulin Resistance, Lipohypertrophy
- Being tested
- Embrace Patch
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embrace PatchDevice
Tension offloading skin patch
| Study group | Role | What they receive |
|---|---|---|
| embrace patch treatment | Experimental | Insulin PK/PD before and after treatment with embrace patch Receives: Device: Embrace Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin
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
Measured: 16 weeks
Secondary outcomes (1)
Effects of embrace on lipohypertrophic tissue could result in beneficial effects on volume and subsequent remodeling of the lipohypertrophic tissue histology.
To investigate the effect of four months of treatment with embrace® on volume (mL) of the target lipohypertrophic lesion comparing baseline to EoT in trial participants with type 1 diabetes and lipohypertrophy. To investigate the effect of four months of natural healing of a LH comparator lesion volume (mL) from baseline to EoT in trial participants with type 1 diabetes and lipohypertrophy. Measurements will be taken by ultrasound.
Measured: From enrollment to the end of treatment of 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start16 Feb 2024
- Primary completion18 Dec 2024
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre / Post comparison with device treatment for 16 weeks.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neodyne Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Stoffel, Doctor, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025513
- Sponsor's protocol ID
- CA006
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety and Efficacy of Embrace, De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy (LH)
- ClinicalTrials.gov ID
- NCT06025513
- Acronym / sponsor ID
- CA006
- Conditions
- Insulin Resistance, Lipohypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Neodyne Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 6 Sep 2023 (actual)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre / Post comparison with device treatment for 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| embrace patch treatment | Experimental | Device: Embrace PatchInsulin PK/PD before and after treatment with embrace patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Embrace PatchTension offloading skin patch | Device | embrace patch treatment |
Primary outcome
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
1 secondary outcome
Effects of embrace on lipohypertrophic tissue could result in beneficial effects on volume and subsequent remodeling of the lipohypertrophic tissue histology.
Time frame: From enrollment to the end of treatment of 16 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 7 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Marc Stoffel, Doctor principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embrace Patch in people with Insulin Resistance and Lipohypertrophy, run by Neodyne Biosciences, Inc. 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 10 inclusion and 16 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 7 Aug 2025. 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.
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?
Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin (time frame: 16 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 7 Aug 2025.