A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients
Transdermal Delivery Solutions Corp
Summary
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.
Description
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…
Eligibility
- Age range
- 25–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. 25 and 75 years of age, inclusive. 3. The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent. 4. The subject has a body mass index (BMI) within 18-50 kg/m2. 5. The subject is in otherwise good health as determined by medic…
Interventions
- BiologicalHuman Insulin
International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins.
- DeviceFinger-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.
Location
- Langford Research InstitutePalm Beach Gardens, Florida