Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken

• with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization

• with a glycemic target of HbA1c <= 7%

• with HbA1c at inclusion >7% and <=9%

• Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)

Exclusion Criteria:

• contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin

• acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk

Other protocol defined inclusion/exclusion criteria may apply