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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01339143
• Other study ID #: AN10016-002
• Status: Recruiting
• Phase: Phase 4
• First received: April 15, 2011
• Last updated: May 5, 2011
• Start date: April 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2010
• Source: Korea University Anam Hospital
• Contact: Sin-Gon Kim, Dr., Ph.D.
• Phone: 82-2-920-5830
• Email: k50367[@]korea.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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, a-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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Oxidative Stress

Intervention

Drug:
• Galvus (vildagliptin)
50mg BID, PO, for 16 weeks
• pioglitazone
15mg, QD, PO, 16 weeks

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Variability		16 weeks	No
Secondary	Oxidative stress		16 weeks	No
Secondary	HbA1C		16 weeks	No
Secondary	hypoglycemia		16 weeks	Yes