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

Novartis Pharmaceuticals40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Changhua, Taiwan

Outcomes

Primary Outcomes

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

HbA1c analysis will be performed on a blood sample obtained by study personnel.

Time frame: Baseline, Week 24

Secondary Outcomes

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

HbA1c analysis will be performed on a blood sample obtained by study personnel.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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