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

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ClinicalTrials.gov Identifier: NCT01099137
Recruitment Status : Completed
First Posted : April 6, 2010
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes Drug: Vildagliptin Drug: Sulphonylurea dose-up Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vildagliptin
Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin
Drug: Vildagliptin
Vildagliptin 50mg twice a day, orally, for 24 weeks
Other Name: Galvus

Active Comparator: Sulphonylurea dose-up
Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin
Drug: Sulphonylurea dose-up
glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin
Other Name: Amaryl




Primary Outcome Measures :
  1. The change of HbA1c [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. Fasting Plasma Glucose (FPG) [ Time Frame: 24 weeks ]
  2. Postprandial Plasma Glucose (PPG) [ Time Frame: 24 weeks ]
  3. Hypoglycemia [ Time Frame: 24 weeks ]
  4. Body weight [ Time Frame: 24 weeks ]
  5. HbA1c < 7.0% without hypoglycemia [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT01099137


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Soo Lim, MD,PHD Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01099137     History of Changes
Other Study ID Numbers: SNUBH_ENDO3
First Posted: April 6, 2010    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
Diabetes
Vildagliptin
insulin
C-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action