Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin (ADDONIS)

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Vildagliptin; Drug: Basal Insulin; Drug: sulfonylurea (SU); Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01871558

CLAF237AFR07

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

SU+metformin + Basal Insulin

Active Comparator group

Description:

Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG

Treatment:

Drug: sulfonylurea (SU)

Drug: Metformin

Drug: Basal Insulin

Metformin/vildagliptin + Basal Insulin

Experimental group

Description:

Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG

Treatment:

Drug: Metformin

Drug: Basal Insulin

Drug: Vildagliptin