Pioglitazone Versus Metformin in Type 2 Diabetes

NCT ID: NCT00815399

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

15-45 mg/die

2

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

500-2000 mg/die

Interventions

Pioglitazone

15-45 mg/die

Intervention Type: DRUG

Metformin

500-2000 mg/die

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Dario Giugliano

Prof of Endocrinology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Geriatrics and Metabolic Diseases

Naples, , Italy

Countries

Italy

References

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. doi: 10.1001/jama.296.21.joc60158. Epub 2006 Nov 13.

Reference Type: BACKGROUND

PMID: 17101640 (View on PubMed)

Other Identifiers

DMD/2007/10

Identifier Type: -

Identifier Source: org_study_id