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Pioglitazone Versus Metformin in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Second University of Naples.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00815399
First received: December 29, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

Type 2 diabetes is an epidemic. Its long-term consequences translate into enormous human suffering and economic costs; however, much of the morbidity associated with long-term microvascular and neuropathic complications can be substantially reduced by interventions that achieve glucose levels close to the nondiabetic range. However, none of the recent intervention studies has demonstrated a benefit of intensive glycemic control on their primary CVD outcomes.

The investigators report the findings of a long-term randomized and comparator-controlled clinical trial conducted in patients with newly-diagnosed type 2 diabetes. The investigators compared the effect of pioglitazone with that of metformin on circulating endothelial cell-derived submicroscopic membranous vesicles, termed microparticles: because of their putative role in inflammatory processes and their ability to directly affect endothelial functions, they are gaining increasing popularity as a surrogate marker of cardiovascular outlook. Metformin was chosen as a comparator because the American Diabetes Association recommendations suggest to start therapy in newly-diagnosed type 2 diabetic subjects combining a drug (metformin) with lifestyle changes. Moreover, the mechanism of action of pioglitazone is distinct from that of metformin.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Pioglitazone
Drug: Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone Compared With Metformin on Endothelial Microparticles in Type 2 Diabetes. A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Circulating Endothelial microparticles [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Glucose profile, lipid profile, hemoglobin A1c, carotid intima-media thickness [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pioglitazone
15-45 mg/die
Active Comparator: 2 Drug: Metformin
500-2000 mg/die

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 30-75 years, with newly-diagnosed type 2 diabetes (according to the ADA criteria) and never treated with antihyperglycemic drugs, were selected for the study. Inclusion criteria also included a body mass index (BMI) >25 kg/m2, and HbA1c level <10%.

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Any investigational drug within the previous 3 months
  • Use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
  • Presence of any clinically relevant somatic or mental diseases that anticipated poor adherence to diet regimens
  • To minimize the likelihood of including subjects with late-onset type 1 diabetes, candidates with a positive test for anti-GAD antibody or with fasting plasma C-peptide less than 0.76 ng/L (<0.25 pmol/L) were excluded
  • Also excluded were patients with abnormal laboratory tests, including liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) greater than 3 times the upper limit of normal, and serum creatinine greater than 123.8 μmol/L (1.4 mg/dL).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815399

Locations
Italy
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
Second University of Naples
  More Information

Publications:

Responsible Party: Department of Geriatrics and Metabolic Diseases
ClinicalTrials.gov Identifier: NCT00815399     History of Changes
Other Study ID Numbers: DMD/2007/10
Study First Received: December 29, 2008
Last Updated: December 29, 2008
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013