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

Insulin Resistance Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025513
• Other study ID #: CA006
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Neodyne Biosciences, Inc.
• Contact: Jasper Jackson
• Phone: 1-800-519-7127
• Email: jjackson[@]neodynebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Subject with type 1 diabetes for at least 3 years

3. 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.

4. Treated with multiple daily injections (=3) of insulin for at least 2 years or continuous subcutaneous insulin infusion for at least 1 year.

5. Subject is willing and able to continue same basal insulin during trial participation.

6. Body Mass Index (BMI) 18.5 to 30.0 kg/m², inclusive

7. HbA1c at screening between 6.5% and 9.5% (inclusive)

8. Have clinical laboratory test results within the normal range for the population, or with abnormalities deemed clinically insignificant by the investigator.

9. Considered generally healthy (apart from type 1 diabetes and lipohypertrophy) upon completion of medical history and screening safety assessments, as judged by the Investigator

10. Have venous access sufficient to allow cannulation for blood sampling as required by the protocol

Exclusion Criteria:

1. 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

2. 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)

3. 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.

4. Signs of acute illness as judged by the Investigator

5. Any serious systemic infectious disease during four weeks prior to screening, as judged by the Investigator.

6. Aspartate transaminase (AST) and/or Alanine transaminase (ALT) > 2 times the upper limit of normal

7. Estimated glomerular filtration rate (eGFR)<60 mL/min

8. 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)

9. Heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.

10. History of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months

11. 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

12. A positive result in the alcohol and/or urine drug screen at the screening visit

13. Tested positive for Hepatitis Bs antigen

14. 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)

15. Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen

16. 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

Related Conditions & MeSH terms

• Insulin Resistance
• Lipohypertrophy

Intervention

Device:
• Embrace Patch
Tension offloading skin patch

Locations

Country	Name	City	State
Germany	Profil	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Neodyne Biosciences, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 weeks