Type 2 Diabetes
Conditions
Brief summary
Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of \<7%. AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.
Detailed description
* Source data verification: paper or electronic medical records. * Statistical analysis: All analyses will compare the randomly assigned treatment groups under the intention- to-treat principle
Interventions
DRUGGlimepiride
Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
DRUGVildagliptin
Reduce to 50 mg if estimated glomerular filtration rate (eGFR) \<45 mL/min
DRUGPioglitazone
Start with 15 mg/day and advance to 30 mg/day
DRUGCanagliflozin
Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly-diagnosed, type 2 diabetic patients, failing to diet
Exclusion criteria
* Suspected type 1 diabetes or secondary diabetes resulting from specific causes * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is maintenance of metabolic control (glycemic durability), defined as time to primary failure with a HbA1c value >7% on maximally tolerated doses of the assigned drug. | Six years |
Secondary
| Measure | Time frame |
|---|---|
| Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up | 6 years |
Other
| Measure | Time frame |
|---|---|
| Changes of low density lipoprotein cholesterol level from baseline each year of follow up | 6 years |
| Changes of high density lipoprotein cholesterol level from baseline each year of follow up | six years |
| Changes of triglyceride level from baseline each year of follow up | 6 years |
Countries
Italy
Contacts
Primary ContactDario Giugliano, MD
Outcome results
None listed