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

Novartis Pharmaceuticals150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Type 2 Diabetes Mellitus

Interventions

vildagliptinDRUG

Drug 50mg vildagliptin bid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Investigative site

Cairo, Egypt

Outcomes

Primary Outcomes

Evaluate the safety and tolerability of vildagliptin 50 mg bid

Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.