impaired glucose tolerance (IGT) MedDRA version: 12.0 Level: HLT Classification code 10020638 Term: Hyperglycaemic conditions NEC
Conditions
Interventions
Product Name: recombinant human insulin
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: Rec Human Insulin
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 1-
Sponsors
UNIVERSITA` CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Normal fasting glucose and post-prandial glucose levels between 140 to 199 mg/dL; 2. Be male or female between the ages 18 to 80 years; 3. Availability for the entire study period and willingness to adhere to protocol requirements as evidenced by a signed, written, informed consent; 4. Current physical examination, vital signs or ECG at screening that reveals no clinically significant abnormalities; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: . Known history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, kidney disease, or conditions known to interfere with the absorption, distribution, metabolism or excretion of insulin; 2. Any clinically significant illness during the four (4) weeks prior to entry into this study; 3. Have a history of drug or alcohol abuse or psychological disease that in the opinion of the Investigator would interfere with participation in the protocol; 4. Use of enzyme inducing and enzyme inhibiting drugs such as phenobarbital, and carbamazepine within 30 days prior to entry into this study; 5. Have positive pregnancy test, or is a breast feeding woman , or a woman not using an adequate method of contraception; 6. Have a history of diabetes; 7. Have any acute illness within the 2 weeks prior to screening; 8. Have elevated liver enzymes ALT, AST, gamma-glutamyl transpeptidase or alkaline phosphatase 3 times the upper limit of normal; 9. Have received any investigational drug within 30 days prior to screening requiring blood donation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of this study is the reduction of HbA1c of 0.3 % at 6 month treatment between experimental vs control group;Secondary Objective: - the evaluation of glucose variability measured with CGMS at 3 and 6 months treatment between experimental vs control group; - changes in body weight; - number of hypoglycemic events.;Primary end point(s): evaluation of the long term effect of oral spray insulin on metabolic control (HbA1c and glucose variability) in subjects with Impaired Glucose Tolerance | — |
Countries
Italy
Outcome results
None listed