NCT02142309

Glycemic Durability After Metformin Failure

Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Glimepiride	Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
DRUG	Vildagliptin	Reduce to 50 mg if estimated glomerular filtration rate (eGFR) \<45 mL/min
DRUG	Pioglitazone	Start with 15 mg/day and advance to 30 mg/day
DRUG	Canagliflozin	Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring

Timeline

• Start date: 2005-10-01
• Primary completion: 2015-10-01
• Completion: 2017-01-01
• First posted: 2014-05-20
• Last updated: 2016-04-20

Locations

2 sites across 1 country: Italy