Back to resultsEffects of Vildagliptine and Glimepiride on Glucose Variability
Primary Purpose
Diabetes Mellitus, Non-Insulin-Dependent
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Glimepiride
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent
Eligibility Criteria
Inclusion Criteria:
- with type 2 DM
- with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
- who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
- who can be applied with CGMS
Exclusion Criteria:
- who has liver function abnormality or renal function abnormality
- who has any kind of diseases, operations, medical treatments that can affect glucose levels
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glimepiride
Vildagliptin
Arm Description
Starting with Glimepiride. After 3 month, switching to vildagliptin.
Starting with vildagliptin. After 3 month, switching to Glimepiride.
Outcomes
Primary Outcome Measures
Glycemic variability index
Cardiovascular disease risk factor
Secondary Outcome Measures
glucose profile and lipid profile
hypoglycemic index
Full Information
NCT ID
NCT01812122
First Posted
March 13, 2013
Last Updated
November 19, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01812122
Brief Title
Effects of Vildagliptine and Glimepiride on Glucose Variability
Official Title
Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.
Detailed Description
We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%).
Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glimepiride
Arm Type
Experimental
Arm Description
Starting with Glimepiride. After 3 month, switching to vildagliptin.
Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Starting with vildagliptin. After 3 month, switching to Glimepiride.
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Glycemic variability index
Time Frame
before and after 3 months of each drug administration
Title
Cardiovascular disease risk factor
Time Frame
before and after 3 months of each drug administration
Secondary Outcome Measure Information:
Title
glucose profile and lipid profile
Time Frame
before and after 3 months of each drug administration
Title
hypoglycemic index
Time Frame
before and after 3 months of each drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
with type 2 DM
with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
who can be applied with CGMS
Exclusion Criteria:
who has liver function abnormality or renal function abnormality
who has any kind of diseases, operations, medical treatments that can affect glucose levels
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Seung Jung, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Vildagliptine and Glimepiride on Glucose Variability
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