NCT01871558

Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Vildagliptin	50 mg b.i.d
DRUG	Metformin	metformin is to be kept unchanged
DRUG	sulfonylurea (SU)
DRUG	Basal Insulin

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-06-06
• Last updated: 2016-04-21
• Results posted: 2016-03-23

Locations

19 sites across 1 country: France