Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426802

CLAF237AEG01

Details and patient eligibility

About

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who sign the informed consent
• HbA1c in the range of > 7 to ≤10.5% at Visit 1
• Ability to comply with all study requirements

Exclusion criteria

• Pregnant or lactating women
• Serious cardiovascular disorders
• Liver/renal disease or dysfunction
• Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
• Laboratories values abnormalities as defined by the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Vildagliptin 50 bid

Experimental group

Treatment:

Drug: vildagliptin