Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Metformin; Drug: Sitagliptin; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860288

CLAF237B2224

Details and patient eligibility

About

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Enrollment: 1,988 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18-78 years old inclusive at Visit 1
• T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
• Patient agreement to maintain same dose of metformin throughout study
• HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
• Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion criteria

• Pregnant or nursing (lactating) women
• FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,988 participants in 4 patient groups, including a placebo group

Vildagliptin Dose 1

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Metformin

Vildagliptin Dose 2

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Metformin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Metformin

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin

Drug: Metformin