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

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Diabetes Mellitus Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pioglitazone

pioglitazone: 15mg, QD, PO, 16 weeks

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

15mg, QD, PO, 16 weeks

vildagliptin

vildagliptin 50mg,BID,PO,16 weeks

Group Type EXPERIMENTAL

Galvus (vildagliptin)

Intervention Type DRUG

50mg BID, PO, for 16 weeks

Interventions

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Galvus (vildagliptin)

50mg BID, PO, for 16 weeks

Intervention Type DRUG

pioglitazone

15mg, QD, PO, 16 weeks

Intervention Type DRUG

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No