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Pioglitazone Versus Metformin in Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Dario Giugliano, Second University of Naples Identifier:
First received: December 29, 2008
Last updated: November 17, 2015
Last verified: November 2015

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Circulating Endothelial microparticles [ Time Frame: six months ]

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

Enrollment: 150
Study Start Date: October 2007
Study Completion Date: April 2015
Primary Completion Date: March 2015 (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


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT00815399

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

Responsible Party: Dario Giugliano, Prof of Endocrinology and Metabolism, Second University of Naples Identifier: NCT00815399     History of Changes
Other Study ID Numbers: DMD/2007/10
Study First Received: December 29, 2008
Last Updated: November 17, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 28, 2017