Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Vildagliptine and Glimepiride on Glucose Variability

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 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: November 21, 2014
Last verified: November 2014
  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: 16
Study Start Date: March 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 21, 2014
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014