Pioglitazone Versus Metformin in Type 2 Diabetes

University of Campania "Luigi Vanvitelli"

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Metformin

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT00815399

DMD/2007/10

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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).