Effects of Vildagliptine and Glimepiride on Glucose Variability

This study is currently recruiting participants.
Verified March 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hye Seung Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01812122
First received: March 13, 2013
Last updated: March 14, 2013
Last verified: March 2013

March 13, 2013
March 14, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
  • Glycemic variability index [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: No ]
  • Cardiovascular disease risk factor [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01812122 on ClinicalTrials.gov Archive Site
  • glucose profile and lipid profile [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: No ]
  • hypoglycemic index [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Vildagliptine and Glimepiride on Glucose Variability
Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
  • Drug: Glimepiride
  • Drug: Vildagliptin
  • Experimental: Glimepiride
    Starting with Glimepiride. After 3 month, switching to vildagliptin.
    Interventions:
    • Drug: Glimepiride
    • Drug: Vildagliptin
  • Experimental: Vildagliptin
    Starting with vildagliptin. After 3 month, switching to Glimepiride.
    Interventions:
    • Drug: Glimepiride
    • Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Hye Seung Jung, MD +82-2-2072-0240 jungjhs@gmail.com
Korea, Republic of
 
NCT01812122
CGMS_SU_Gliptin
Yes
Hye Seung Jung, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Hye Seung Jung, MD Seoul National University Hospital
Seoul National University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP