Clinical trial NCT01099137: Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin
Official title: The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetes
Vildagliptin
insulin
C-peptide
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change of HbA1c
timeFrame: 24weeks
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: 24 weeks
measure: Postprandial Plasma Glucose (PPG)
timeFrame: 24 weeks
measure: Hypoglycemia
timeFrame: 24 weeks
measure: Body weight
timeFrame: 24 weeks
measure: HbA1c < 7.0% without hypoglycemia
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong AR, Lee J, Ku EJ, Hwangbo Y, Kim KM, Moon JH, Choi SH, Jang HC, Lim S. Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial. Diabetes Res Clin Pract. 2015 Jul;109(1):141-8. doi: 10.1016/j.diabres.2015.04.019. Epub 2015 May 5.