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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Glimepiride
Drug: Vildagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: March 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glimepiride
Starting with Glimepiride. After 3 month, switching to vildagliptin.
Drug: Glimepiride Drug: Vildagliptin
Experimental: Vildagliptin
Starting with vildagliptin. After 3 month, switching to Glimepiride.
Drug: Glimepiride Drug: Vildagliptin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812122

Contacts
Contact: Hye Seung Jung, MD +82-2-2072-0240 jungjhs@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyeong Seon Park, MD    +82-2-2072-2228    yurica514@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hye Seung Jung, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hye Seung Jung, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01812122     History of Changes
Other Study ID Numbers: CGMS_SU_Gliptin
Study First Received: March 13, 2013
Last Updated: March 14, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014