Glycemic Durability After Metformin Failure
Phase 4
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT02142309
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glimepiride Glimepiride up to 4 mg/day Vildagliptin Vildagliptin 50 mg bid Pioglitazone Pioglitazone up to 30 mg/day Canagliflozin Canagliflozin 300 mg/day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up 6 years
Trial Locations
- Locations (2)
Department of Geriatrics and Metabolic Diseases
🇮🇹Naples, Italy
Katherine Esposito
🇮🇹Naples, Italy