Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin

Diabetes Clinical Trial

Official title:

The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099137
• Other study ID #: SNUBH_ENDO3
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2010
• Last updated: May 26, 2014
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Vildagliptin
Vildagliptin 50mg twice a day, orally, for 24 weeks
• Sulphonylurea dose-up
glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of HbA1c		24weeks	Yes
Secondary	Fasting Plasma Glucose (FPG)		24 weeks	Yes
Secondary	Postprandial Plasma Glucose (PPG)		24 weeks	Yes
Secondary	Hypoglycemia		24 weeks	Yes
Secondary	Body weight		24 weeks	Yes
Secondary	HbA1c < 7.0% without hypoglycemia		24 weeks	Yes