Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
NCT00975065 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 266
Last updated 2012-08-23
Summary
The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Conditions
Interventions
- DRUG
-
vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
vildagliptin 50 mg bid plus metformin 1500mg
- DRUG
-
metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
metformin 1500mg plus metformin 500mg or 1000mg
Sponsors & Collaborators
-
Handok Inc.
lead INDUSTRY
Principal Investigators
-
Sei Hyun Baik, professor · Korea University Guro Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2011-12-31
- Completion
- 2012-04-30
Countries
- South Korea
Study Locations
More Related Trials
-
Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
NCT01196546 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)
NCT00728351 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.
NCT03577184 ·Status: WITHDRAWN
-
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
NCT01766778 ·Status: COMPLETED ·Phase: PHASE4
-
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy
NCT01398592 ·Status: COMPLETED ·Phase: PHASE4
-
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
NCT00468039 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
NCT01404676 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.
NCT03088670 ·Status: COMPLETED ·Phase: PHASE3
-
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
NCT00106340 ·Status: COMPLETED ·Phase: PHASE3
-
Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
NCT00494884 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
NCT00396357 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
NCT00382096 ·Status: COMPLETED ·Phase: PHASE3
-
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
NCT06851962 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
NCT01169090 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
NCT00099892 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Vildagliptine and Glimepiride on Glucose Variability
NCT01812122 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
NCT00237250 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin
NCT01099137 ·Status: COMPLETED ·Phase: PHASE4
-
Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2
NCT07076056 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
NCT01582243 ·Status: COMPLETED ·Phase: PHASE4
-
Acute and Short-term Chronic Effects of Galvus (Vildagliptin) in Diabetes Type 2 Obese Women
NCT01827280 ·Status: COMPLETED ·Phase: PHASE4
-
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
NCT00138515 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
NCT01882907 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
NCT00860288 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
NCT00751114 ·Status: COMPLETED ·Phase: PHASE4