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

• Sponsor: Korea University Anam Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01339143
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Oxidative Stress	Drug: Galvus (vildagliptin); Drug: pioglitazone	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pioglitazone pioglitazone: 15mg, QD, PO, 16 weeks	Drug: pioglitazone; 15mg, QD, PO, 16 weeks
Experimental: vildagliptin vildagliptin 50mg,BID,PO,16 weeks	Drug: Galvus (vildagliptin); 50mg BID, PO, for 16 weeks

Outcome Measures

Primary Outcome Measures

1. Glycemic Variability [16 weeks]

Secondary Outcome Measures

1. Oxidative stress [16 weeks]

2. HbA1C [16 weeks]

3. hypoglycemia [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Korea University Anam Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01339143
• Other Study ID Numbers: AN10016-002
• First Posted: Apr 20, 2011
• Last Update Posted: May 9, 2011
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Vildagliptin
• Additional relevant MeSH terms: Diabetes Mellitus; Pioglitazone; Vildagliptin

Study Results

No Results Posted as of May 9, 2011