Status:
COMPLETED
Pioglitazone Versus Metformin in Type 2 Diabetes
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
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 neurop...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00815399
Start Date
October 1 2007
End Date
April 1 2015
Last Update
November 18 2015
Active Locations (1)
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1
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138