Compare the Effect of DPP-IV Inhibitor or TZD on Glycemic Variability and Oxidative Stress in Patient With 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.

Detailed Description
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Activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. Dipeptidyl peptidase IV (DPP-IV), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. We believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.

Official Title
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An Open-label, Randomized, Active-controlled Study to Compare the Effect of DPP-IV Inhibitor and TZD as add-on Therapy to Metformin on Glycemic Variability and Oxidative Stress in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Conditions
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Diabetes Mellitus, Oxidative Stress

Intervention / Treatment
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* Drug: Galvus (vildagliptin)
* Drug: pioglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female with age 18-80 years Type 2 diabetes mellitus On stable dose of metformin (more than 1000mg) for at least 1 month HbA1c 7 10% Subjects on statins, ACE inhibitors, ARBs and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study BP under control - no change required to BP medications Agreement to maintain prior diet & exercise Exclusion Criteria: Type 1 DM or Any kind of secondary DM Pregnant or lactating women. Treatment with sulfonylurea, α-glucosidase inhibitor, glinide, GLP-1 analogues, DPP-IV inhibitors or insulin therapy within 1 month prior to informed consent. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent. HbA1c <7% or >10% Uncontrolled hypertension ( BP > 160/100 mmHg) Congestive heart failure (NYHA class I to IV).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pioglitazone<br>pioglitazone: 15mg, QD, PO, 16 weeks | Drug: pioglitazone<br>* 15mg, QD, PO, 16 weeks<br>|
| Experimental: vildagliptin<br>vildagliptin 50mg,BID,PO,16 weeks | Drug: Galvus (vildagliptin)<br>* 50mg BID, PO, for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Variability |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress |  | 16 weeks | 
| HbA1C |  | 16 weeks | 
| hypoglycemia |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vildagliptin