Dose Response Study of Transdermal Human Insulin in Patients

Официальное название

A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients

Обзор

A 21-Day open label study of transdermally delivered human insulin in Type 2 Diabetics as measured by response of down modulation of glucose after dosing of Insulin as compared to historic patient response to injected insulins.

Подробное описание

A 21-Day open label study of transdermally delivered human insulin in 30 Type 2 Diabetics is anticipated. Well-managed Type 2 Diabetics will be added to the protocol from the patient census of practicing diabetologists and family practitioners, with preference given to patients already using a wearable Continuous Glucose Monitor (CGM) system. Once added to the protocol, Subjects will be monitored via CGM for two weeks before change of dose form. Subjects will be required to calibrate the CGM against finger-stick blood sampling and to poll the monitor sensor at least every 8 hours during the 42 days of monitoring including the 21-days on-transdermal-dose study period to ensure continuity of interstitial glucose measurement. Subjects will be monitored for 7 days after the last transdermal dose to monitor interchangeability of the dose forms.

Once baseline data is collected, Subjects will exchange transdermal dosing on a Unit for Unit basis. Trial materials will be formulated to a concentration of 100 IUs per mL and dispensed via 0.2 mL metered, finger-actuated pump sprayer, with each pump delivering 20 IUs of Human Insulin to the skin. If a patient, for example is currently using 120 IUs per day, 40 IUs basal insulin and 80 IUs Insulin Aspart, 120 IUs or 6 sprays would be used.

The study nurse will contact each subject every day of the study to answer questions and encourage compliance with the protocol.

Вмешательства

• Биопрепарат Human Insulin
  International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins.
• Устройство Finger-actuated, Metered Pump Sprayer
  Stock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump.

Первичные конечные точки

• Percentage of Glucose Time in Range for Study Participants [Срок оценки: 21 Days]

Вторичные конечные точки (2)

• Avoidance of Hypoglycemia in Study Participants [Срок оценки: 21 days.]
• Skin Safety in Study Participants [Срок оценки: 21 days dosing plus 7 days post dose follow-up.]

Критерии участия

Критерии включения

• Adult Type 2 Diabetes Mellitus ("T2D") Patients on Insulin Replacement therapy not administered via implanted pump well-managing p.r.n as defined by serum glucose ranging between 85 and 200 mg/dL and no more than 1 hypoglycemic or serious hypoglycemic event within the last 9 months.
• 25 and 75 years of age, inclusive.
• The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.
• The subject has a body mass index (BMI) within 18-50 kg/m2.
• The subject is in otherwise good health as determined by medical history and physical examination.
• The subject's normal insulin dose ranges from between 10 to 200 IU per dose.
• The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose monitor for the pharmacodynamic assessments that the investigators have continuous access to via daily downloads.
• The subject is willing and able to comply with all testing and requirements defined in the protocol.
• The subject is willing and able to return to the study site for all visits.

Критерии исключения

• The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
• The subject has had more than 2 hypoglycemic events in the last month.
• The subject's normal insulin dose is less than 10 and more than 200 IUs.
• Subjects receiving Insulin from an implanted or external insulin pump system.
• The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.
• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D.
• The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.
• The subject has used any prescription medication that may interfere with the evaluation of study medication.
• The subject has donated or lost a significant volume of blood (>450 mL) within four (4) weeks of the study, and subject's Hemoglobin concentration and hematocrit have not returned to within 5% of normal.
• The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
• Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
• Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Langford Research Institute — Palm Beach Gardens

Идентификаторы

NCT: NCT05159453 · LEV201-D-120121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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