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
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|ClinicalTrials.gov Identifier: NCT00975065|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : August 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)||Phase 4|
- The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability.
- Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP.
- Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary.
- Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||April 2012|
Experimental: Galvus group
the combination of metformin plus Vildagliptin:
Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
vildagliptin 50 mg bid plus metformin 1500mg
Active Comparator: Diabex group
metformin alone arm:
Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
metformin 1500mg plus metformin 500mg or 1000mg
- Hemoglobin A1c at 24 weeks [ Time Frame: 32weeks ]
- Hemoglobin A1c at 12 weeks [ Time Frame: 32weeks ]
- Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week [ Time Frame: 32weeks ]
- 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week [ Time Frame: 32weeks ]
- Fasting Lipid profiles at 24 week [ Time Frame: 32weeks ]
- Body weight at 24 week [ Time Frame: 32weeks ]
- Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit [ Time Frame: 32weeks ]
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): NCT00975065
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Principal Investigator:||Sei Hyun Baik, professor||Korea University Guro Hospital|