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Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
University of Athens
Information provided by (Responsible Party):
Nikolaos Kadoglou, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00373178
First received: September 6, 2006
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: rosiglitazone
Drug: metformin
Drug: Anti-diabetic medications
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Novel cardiovascular risk factors modification [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid and glucose regulation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin,lifestyle counselling Drug: rosiglitazone Drug: metformin Drug: Anti-diabetic medications

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Heart failure
  • Renal disease
  • Liver disease
  • Life-threatening diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373178

Locations
Greece
AHEPA University Hospital of Thessaloniki
Thessaloniki, Greece
Aristotle University of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
University of Athens
Investigators
Study Chair: Miltiadis Alevizos, PhD University Hospital AHEPA,Thessaloniki,Greece
  More Information

No publications provided by Aristotle University Of Thessaloniki

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nikolaos Kadoglou, MD,PhD, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00373178     History of Changes
Other Study ID Numbers: 020401975
Study First Received: September 6, 2006
Last Updated: November 1, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
rosiglitazone
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Rosiglitazone
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013