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Glycemic Durability After Metformin Failure

NCT02142309 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2016-04-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Dario Giugliano, MD PHD · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2015-10-31
Completion
2017-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02142309 on ClinicalTrials.gov