Dose Response Study of Transdermal Human Insulin in Patients
ConditionGlucose, High Blood
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age25-75
SponsorTransdermal Delivery Solutions Corp
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Human Insulin
- Finger-actuated, Metered Pump Sprayer
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Transdermal Delivery Solutions Corp
Lead sponsor
Langford Research Institute, Inc.
Collaborator
Source ClinicalTrials.gov