E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
impaired glucose tolerance (IGT) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10020638 |
E.1.2 | Term | Hyperglycaemic conditions NEC |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary endpoint of this study is the reduction of HbA1c of 0.3 % at 6 month treatment between experimental vs control group |
|
E.2.2 | Secondary objectives of the trial |
- 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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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; |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
dieta ed esercizio fisico |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |