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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

NCT00102466

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

NCT00099944

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Effects of Vildagliptine and Glimepiride on Glucose Variability

NCT01812122

Diabetes Mellitus, Non-Insulin-Dependent

COMPLETED PHASE4

Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes

NCT01882907

Type 2 Diabetes

COMPLETED PHASE4

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

NCT02338921

Type 2 Diabetes

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vildagliptin

Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin 50mg twice a day, orally, for 24 weeks

Sulphonylurea dose-up

Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin

Group Type ACTIVE_COMPARATOR

Sulphonylurea dose-up

Intervention Type DRUG

glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vildagliptin

Vildagliptin 50mg twice a day, orally, for 24 weeks

Intervention Type DRUG

Sulphonylurea dose-up

glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Galvus Amaryl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No