Glycemic Durability After Metformin Failure

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Canagliflozin; Glimepiride; Metformin; Pioglitazone; Vildagliptin

Criteria

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