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Effects of Vildagliptine and Glimepiride on Glucose Variability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01812122
First Posted: March 15, 2013
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hye Seung Jung, Seoul National University Hospital
  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
Intervention Model: Crossover Assignment
Masking: None (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 Hye Seung Jung, Seoul National University Hospital:

Primary Outcome Measures:
  • Glycemic variability index [ Time Frame: before and after 3 months of each drug administration ]
  • Cardiovascular disease risk factor [ Time Frame: before and after 3 months of each drug administration ]

Secondary Outcome Measures:
  • glucose profile and lipid profile [ Time Frame: before and after 3 months of each drug administration ]
  • hypoglycemic index [ Time Frame: before and after 3 months of each drug administration ]

Enrollment: 16
Study Start Date: March 2013
Study Completion Date: October 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812122


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hye Seung Jung, MD Seoul National University Hospital
  More Information

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
First Submitted: March 13, 2013
First Posted: March 15, 2013
Last Update Posted: November 20, 2015
Last Verified: November 2015

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