NCT01812122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.4 years

First QC Date

March 13, 2013

Last Update Submit

November 19, 2015

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (2)

  • Glycemic variability index

    before and after 3 months of each drug administration

  • Cardiovascular disease risk factor

    before and after 3 months of each drug administration

Secondary Outcomes (2)

  • glucose profile and lipid profile

    before and after 3 months of each drug administration

  • hypoglycemic index

    before and after 3 months of each drug administration

Study Arms (2)

Glimepiride

EXPERIMENTAL

Starting with Glimepiride. After 3 month, switching to vildagliptin.

Drug: GlimepirideDrug: Vildagliptin

Vildagliptin

EXPERIMENTAL

Starting with vildagliptin. After 3 month, switching to Glimepiride.

Drug: GlimepirideDrug: Vildagliptin

Interventions

GlimepirideDRUG
GlimepirideVildagliptin
VildagliptinDRUG
GlimepirideVildagliptin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • who has liver function abnormality or renal function abnormality
  • who has any kind of diseases, operations, medical treatments that can affect glucose levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepirideVildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hye Seung Jung, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

KR(1)