Diabetes
Conditions
Keywords
Diabetes, Vildagliptin, insulin, C-peptide
Brief summary
Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes. In this setting, use of insulin is often the next therapeutic step. Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical practice. It is well established that DPP-IV inhibitor improve glycemic control in patients with type 2 diabetes. But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
Interventions
DRUGVildagliptin
Vildagliptin 50mg twice a day, orally, for 24 weeks
DRUGSulphonylurea dose-up
glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * HbA1c ≥ 7% * Age ≥ 18
Exclusion criteria
* Contraindication to Vildagliptin * Pregnant or breast feeding women * Type 1 diabetes, gestational diabetes, or diabetes with secondary cause * Chronic hepatitis B or C (except healthy carrier of HBV) * Liver disease (AST/ALT \> 3-fold the upper limit of normal) * Renal failure (Cr \> 2.0) * Cancer within 5 years * Not appropriate for oral antidiabetic agent * Medication which affect glycemic control * Disease which affect efficacy and safety of drugs * Other clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c | 24weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose (FPG) | 24 weeks |
| Postprandial Plasma Glucose (PPG) | 24 weeks |
| Hypoglycemia | 24 weeks |
| Body weight | 24 weeks |
| HbA1c < 7.0% without hypoglycemia | 24 weeks |
Countries
South Korea
Outcome results
None listed