Effects of vildaglipitin and glimepiride on variability of glycemic values and cardiovascular risk in diabetic patients is not well controlled with insulin evening

• Conditions: type 2 diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-002955-13-IT
• Lead Sponsor: AFAR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-30
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

- age between 40 and 80 years
- Both sexes
- Treated with metformin and basal insulin
- With HbA1c between 7-9%
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 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Type 1 diabetes;
- Chronic systemic diseases, immunologic, neoplastic;
- Cardiovascular, renal and hepatic
- AST, ALT 2 times higher than the reference values
- Women who are pregnant or intend to become pregnant
- Breastfeeding women.
- Drug therapy can interfere with glucose metabolism

Study & Design

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