NCT00373178

Brief Summary

The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

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

January 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 2, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

September 6, 2006

Last Update Submit

November 1, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

rosiglitazonemetformin

Outcome Measures

Primary Outcomes (1)

  • Novel cardiovascular risk factors modification

    2 years

Secondary Outcomes (1)

  • Lipid and glucose regulation

    2 years

Study Arms (1)

Metformin,lifestyle counselling

ACTIVE COMPARATOR
Drug: rosiglitazoneDrug: metforminDrug: Anti-diabetic medications

Interventions

rosiglitazoneDRUG
Metformin,lifestyle counselling
metforminDRUG
Metformin,lifestyle counselling
Anti-diabetic medicationsDRUG
Metformin,lifestyle counselling

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recently diagnosed type 2 diabetes
  • No previous anti-diabetic medications

You may not qualify if:

  • Heart failure
  • Renal disease
  • Liver disease
  • Life-threatening diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AHEPA University Hospital of Thessaloniki

Thessaloniki, Greece

Location

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (2)

  • Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

    PMID: 32501595DERIVED

  • Kadoglou NP, Tsanikidis H, Kapelouzou A, Vrabas I, Vitta I, Karayannacos PE, Liapis CD, Sailer N. Effects of rosiglitazone and metformin treatment on apelin, visfatin, and ghrelin levels in patients with type 2 diabetes mellitus. Metabolism. 2010 Mar;59(3):373-9. doi: 10.1016/j.metabol.2009.08.005. Epub 2009 Oct 7.

    PMID: 19815243DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

RosiglitazoneMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Miltiadis Alevizos, PhD

    University Hospital AHEPA,Thessaloniki,Greece

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

June 1, 2008

Last Updated

November 2, 2012

Record last verified: 2012-11

Locations

GR(2)