Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT01582243|
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Vildagliptin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Vildagliptin plus metformin (SPC)
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
Other Name: LAF237, Galvus Met
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ]HbA1c analysis will be performed on a blood sample obtained by study personnel.
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: week 12, week 24 ]Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582243
|Novartis Investigative Site|
|Changhua, Taiwan, 500|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|