Studio aperto per la valutazione dell efficacia dell insulina spray buccale sul controllo glicometabolico in soggetti con ridotta tolleranza ai carboidrati (studio PREVORAL 2). - PREVORAL 2

• Conditions: impaired glucose tolerance (IGT); MedDRA version: 12.0Level: HLTClassification code 10020638Term: Hyperglycaemic conditions NEC

• Registration Number: EUCTR2009-016022-14-IT
• Lead Sponsor: IVERSITA` CAMPUS BIOMEDICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified