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De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy

Primary Purpose

Insulin Resistance, Lipohypertrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Embrace Dressing
Sponsored by
Neodyne Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    embrace dressing treatment

    Arm Description

    Insulin PK/PD before and after treatment with embrace dressing

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    September 18, 2023
    Sponsor
    Neodyne Biosciences, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06025513
    Brief Title
    De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Neodyne Biosciences, Inc.

    4. Oversight

    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

    5. Study Description

    Brief 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. 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 bandage 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 bandage 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 bandage with a hole. A needle biopsy will be taken from the LH lesion at baseline and again at study completion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance, Lipohypertrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pre / Post comparison with device treatment for 16 weeks.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    29 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    embrace dressing treatment
    Arm Type
    Experimental
    Arm Description
    Insulin PK/PD before and after treatment with embrace dressing
    Intervention Type
    Device
    Intervention Name(s)
    Embrace Dressing
    Intervention Description
    Tension offloading skin dressing
    Primary Outcome Measure Information:
    Title
    Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin
    Description
    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
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy

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