Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
450 participants
INTERVENTIONAL
2005-10-31
2017-01-31
Brief Summary
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AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.
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Detailed Description
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* Statistical analysis: All analyses will compare the randomly assigned treatment groups under the intention- to-treat principle
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Glimepiride
up to 4 mg/day
Glimepiride
Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
Vildagliptin
50 mg bid
Vildagliptin
Reduce to 50 mg if estimated glomerular filtration rate (eGFR) \<45 mL/min
Pioglitazone
up to 30 mg/day
Pioglitazone
Start with 15 mg/day and advance to 30 mg/day
Canagliflozin
300 mg/day
Canagliflozin
Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring
Interventions
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Glimepiride
Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
Vildagliptin
Reduce to 50 mg if estimated glomerular filtration rate (eGFR) \<45 mL/min
Pioglitazone
Start with 15 mg/day and advance to 30 mg/day
Canagliflozin
Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current or previous (within past 3 months) treatment with any investigational drug
* Any major cardiovascular event in previous year
* Plans for pregnancy during the course of the study for women of childbearing potential
* Serum creatinine level \>1.3 mg/dL in women and \>1.4 mg/dL in men
* History of cancer, other than nonmelanoma skin cancer, that required therapy in the 5 years before randomization
* Treatment with oral, loal, systemic glucocorticoids 14. Treatment with atypical antipsychotics
30 Years
70 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Dario Giugliano
Full Prof of Endocrinology and Metbaolism
Principal Investigators
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Dario Giugliano, MD PHD
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Locations
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Katherine Esposito
Naples, Naples, Italy
Department of Geriatrics and Metabolic Diseases
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DGM 7-2006
Identifier Type: -
Identifier Source: org_study_id
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