Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, type 2, vildagliptin
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
Interventions
DRUGVildagliptin
Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline, Week 24 | HbA1c analysis will be performed on a blood sample obtained by study personnel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline, week 12 | HbA1c analysis will be performed on a blood sample obtained by study personnel. |
| Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 | Baseline, week 12, week 24 | FPG analysis will be performed on a blood sample obtained by study personnel. |
| Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 | Baseline, week, week 24 | PPG analysis will be performed on a blood sample obtained by study personnel. |
| Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week | Baseline, week 24 | 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. |
| The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | week 12, week 24 | Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vildagliptin Plus Metformin (SPC) Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Vildagliptin Plus Metformin (SPC) |
|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 40 |
| serious Total, serious adverse events | 1 / 40 |
Outcome results
Primary
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
Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | -0.82 percentage | Standard Deviation 0.759 |
Secondary
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
Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 | Week 12 | -20.6 mg/dL | Standard Deviation 25.2 |
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 | Week 24 | -19.9 mg/dL | Standard Deviation 31.9 |
Secondary
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
Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | -0.82 percentage | Standard Deviation 0.609 |
Secondary
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
Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week | -12.8 mg/dL | Standard Deviation 31.8 |
Secondary
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
Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 | Week 12 | -40.9 mg/dL | Standard Deviation 41.7 |
| Vildagliptin Plus Metformin (SPC) | Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 | Week 24 | -38.3 mg/dL | Standard Deviation 50.6 |
Secondary
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.
Time frame: week 12, week 24
Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vildagliptin Plus Metformin (SPC) | The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | HbA1c ≤ 7.0% Week 24 | 87.2 percentage of participants |
| Vildagliptin Plus Metformin (SPC) | The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | HbA1c ≤ 6.5% Week 12 | 64.1 percentage of participants |
| Vildagliptin Plus Metformin (SPC) | The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | HbA1c ≤ 6.5% Week 24 | 66.7 percentage of participants |
| Vildagliptin Plus Metformin (SPC) | The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | HbA1c ≤ 7.0% Week 12 | 92.3 percentage of participants |