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

Study Overview
=================
Brief 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

Official Title
-----------------
A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Outpatients who were 20 years of age and older with diagnosis of T2DM. 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%. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study. Understood the nature of the study, and had signed informed consent form. Exclusion criteria Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin. Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1. Female patients who needed to lactate during the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin plus metformin (SPC)<br>Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. | Drug: Vildagliptin<br>* Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)<br>* Other names: LAF237, Galvus Met;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | HbA1c analysis will be performed on a blood sample obtained by study personnel. | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | HbA1c analysis will be performed on a blood sample obtained by study personnel. | Baseline, week 12 | 
| Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 | FPG analysis will be performed on a blood sample obtained by study personnel. | Baseline, week 12, week 24 | 
| Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 | PPG analysis will be performed on a blood sample obtained by study personnel. | Baseline, week, week 24 | 
| Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week | Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed. | Baseline, week 24 | 
| The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively. | week 12, week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vildagliptin, Diabetes Mellitus, type 2