Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821977

CLAF237B2201

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 monotherapy.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients at least 18 years of age at Visit 1
• Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
• HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
• Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion criteria

• Pregnant or lactating female
• FPG ≥ 270 mg/dL (≥15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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338 participants in 3 patient groups, including a placebo group

Vildagliptin Dose 1

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

Vildagliptin Dose 2

Experimental group

Treatment:

Drug: Vildagliptin

Drug: Vildagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo