Glycemic Durability After Metformin Failure

Sponsor
University of Campania Luigi Vanvitelli
Study ID
NCT02142309
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2005
Status verified
Nov 2015
Primary completion
Oct 31, 2015
Completion
Jan 31, 2017

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glimepiride
    up to 4 mg/day
  • Experimental: Vildagliptin
    50 mg bid
  • Experimental: Pioglitazone
    up to 30 mg/day
  • Experimental: Canagliflozin
    300 mg/day

Primary Outcome Measure

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. [ Time Frame: Six years ]

Central Contacts

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