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Status:

COMPLETED

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

Lead Sponsor:

Neodyne Biosciences, Inc.

Conditions:

Insulin Resistance

Lipohypertrophy

Eligibility:

All Genders

18-65 years

Phase:

NA

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 t...

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 16 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 13 2025

Estimated Enrollment :

29 Patients enrolled

Trial Details

Trial ID

NCT06025513

Start Date

February 16 2024

End Date

March 13 2025

Last Update

August 7 2025

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Neuss, Germany