Pioglitazone Versus Metformin in Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Pioglitazone Drug: Metformin |
Phase | Phase 4 |
Sponsor | Second University of Naples |
Responsible Party | Second University of Naples |
ClinicalTrials.gov Identifier | NCT00815399 |
First Received | December 29, 2008 |
Last Updated | December 29, 2008 |
Last verified | September 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | December 29, 2008 |
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Last Updated Date | December 29, 2008 |
Start Date | October 2007 |
Estimated Primary Completion Date | April 2009 |
Current Primary Outcome Measures | Circulating Endothelial microparticles [Time Frame: six months] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Glucose profile, lipid profile, hemoglobin A1c, carotid intima-media thickness [Time Frame: six months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Pioglitazone Versus Metformin in Type 2 Diabetes |
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Official Title | Effect of Pioglitazone Compared With Metformin on Endothelial Microparticles in Type 2 Diabetes. A Randomized Trial |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: Pioglitazone 15-45 mg/die Drug: Metformin 500-2000 mg/die |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 150 |
Estimated Completion Date | April 2009 |
Estimated Primary Completion Date | March 2009 |
Eligibility Criteria | 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). |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Italy |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00815399 |
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Other Study ID Numbers | DMD/2007/10 |
Has Data Monitoring Committee | No |
Information Provided By | Second University of Naples |
Study Sponsor | Second University of Naples |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | September 2008 |
Locations[ + expand ][ + ]
Department of Geriatrics and Metabolic Diseases | Naples, Italy, 80138 |
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