Pioglitazone Versus Metformin in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00815399
Recruitment Status : Completed
First Posted : December 30, 2008
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Dario Giugliano, University of Campania "Luigi Vanvitelli"

Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Pioglitazone Drug: Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone Compared With Metformin on Endothelial Microparticles in Type 2 Diabetes. A Randomized Trial
Study Start Date : October 2007
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Pioglitazone
15-45 mg/die

Active Comparator: 2 Drug: Metformin
500-2000 mg/die

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00815399

Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

Responsible Party: Dario Giugliano, Prof of Endocrinology and Metabolism, University of Campania "Luigi Vanvitelli" Identifier: NCT00815399     History of Changes
Other Study ID Numbers: DMD/2007/10
First Posted: December 30, 2008    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 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