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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01339143

Enrollment

Registered

2011-04-20

Start date

2010-04-30

Completion date

2013-05-31

Last updated

2011-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Oxidative Stress

Keywords

Vildagliptin

Brief summary

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

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.

Interventions

DRUGGalvus (vildagliptin)

50mg BID, PO, for 16 weeks

DRUGpioglitazone

15mg, QD, PO, 16 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Glycemic Variability	16 weeks

Secondary

Measure	Time frame
Oxidative stress	16 weeks
HbA1C	16 weeks
hypoglycemia	16 weeks

Countries

South Korea

Contacts

Primary ContactSin-Gon Kim, Dr., Ph.D.

k50367@korea.ac.kr82-2-920-5830

Backup ContactJuri Park, Dr.,Ph.D

poirio@naver.com82-2-2224-2590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026