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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01339143
Recruitment Status : Unknown
Verified April 2010 by Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : April 20, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Korea University Anam Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Glycemic Variability [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Oxidative stress [ Time Frame: 16 weeks ]
  2. HbA1C [ Time Frame: 16 weeks ]
  3. hypoglycemia [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339143


Contacts
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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
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Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University Anam Hospital

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Responsible Party: Sin-Gon Kim, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01339143    
Other Study ID Numbers: AN10016-002
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: April 2010
Keywords provided by Korea University Anam Hospital:
Vildagliptin
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action