Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Korea University Anam Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01339143
First received: April 15, 2011
Last updated: May 5, 2011
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus
Oxidative Stress
 Drug: Galvus (vildagliptin)
Drug: pioglitazone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Glycemic Variability [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxidative stress [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • HbA1C [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • hypoglycemia [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339143

Contacts
Contact: Sin-Gon Kim, Dr., Ph.D. 82-2-920-5830 k50367@korea.ac.kr
Contact: Juri Park, Dr.,Ph.D 82-2-2224-2590 poirio@naver.com

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Sin-Gon Kim, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01339143     History of Changes
Other Study ID Numbers: AN10016-002
Study First Received: April 15, 2011
Last Updated: May 5, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
Vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Vildagliptin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013