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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus
Started Apr 2010
Longer than P75 for phase_4 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 9, 2011
April 1, 2010
2.7 years
April 15, 2011
May 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic Variability
16 weeks
Secondary Outcomes (3)
Oxidative stress
16 weeks
HbA1C
16 weeks
hypoglycemia
16 weeks
Study Arms (2)
Pioglitazone
ACTIVE COMPARATORpioglitazone: 15mg, QD, PO, 16 weeks
vildagliptin
EXPERIMENTALvildagliptin 50mg,BID,PO,16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 20, 2011
Study Start
April 1, 2010
Primary Completion
December 1, 2012
Study Completion
May 1, 2013
Last Updated
May 9, 2011
Record last verified: 2010-04