Overview

Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

Status:
Completed

Trial end date:
2015-09-01

Target enrollment:
0

Participant gender:
All

Summary

This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Metformin
Vildagliptin

Criteria

Inclusion criteria

1. Outpatients who were 20 years of age and older with diagnosis of T2DM.

2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy
at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal.
The glucose control goal was defined as HbA1c ≤ 6.5%.

3. Male or female with child-bearing potential agreed to use an effective method of
contraception approved by the investigator during the study.

4. Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

1. Patients with contraindications mentioned in the Summary of Product Characteristics
for vildagliptin or metformin.

2. Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit
1.

3. Patients with history of hepatic impairment, including but not limited to those with
pretreatment AST or ALT > 3 ULN at Visit 1.

4. Female patients who needed to lactate during the study.