Pioglitazone Versus Metformin in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of Pioglitazone Compared With Metformin on Endothelial Microparticles in Type 2 Diabetes. A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815399
• Other study ID #: DMD/2007/10
• Status: Completed
• Phase: Phase 4
• First received: December 29, 2008
• Last updated: November 17, 2015
• Start date: October 2007
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Pioglitazone
15-45 mg/die
• Metformin
500-2000 mg/die

Locations

Country	Name	City	State
Italy	Department of Geriatrics and Metabolic Diseases	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB Sr, Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006 Dec 6;296(21):2572-81. Epub 2006 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating Endothelial microparticles		six months	Yes
Secondary	Glucose profile, lipid profile, hemoglobin A1c, carotid intima-media thickness		six months	Yes