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

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