NCT02142309

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 20, 2016

Status Verified

November 1, 2015

Enrollment Period

10 years

First QC Date

April 26, 2014

Last Update Submit

April 19, 2016

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up

    6 years

Other Outcomes (3)

  • Changes of low density lipoprotein cholesterol level from baseline each year of follow up

    6 years

  • Changes of high density lipoprotein cholesterol level from baseline each year of follow up

    six years

  • Changes of triglyceride level from baseline each year of follow up

    6 years

Study Arms (4)

Glimepiride

EXPERIMENTAL

up to 4 mg/day

Drug: Glimepiride

Vildagliptin

EXPERIMENTAL

50 mg bid

Drug: Vildagliptin

Pioglitazone

EXPERIMENTAL

up to 30 mg/day

Drug: Pioglitazone

Canagliflozin

EXPERIMENTAL

300 mg/day

Drug: Canagliflozin

Interventions

GlimepirideDRUG

Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily

Glimepiride
VildagliptinDRUG

Reduce to 50 mg if estimated glomerular filtration rate (eGFR) \<45 mL/min

Vildagliptin
PioglitazoneDRUG

Start with 15 mg/day and advance to 30 mg/day

Pioglitazone
CanagliflozinDRUG

Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring

Canagliflozin

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly-diagnosed, type 2 diabetic patients, failing to diet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Katherine Esposito

Naples, Naples, 80138, Italy

RECRUITING

Department of Geriatrics and Metabolic Diseases

Naples, 80138, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepirideVildagliptinPioglitazoneCanagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolidinedionesThiazolesSulfur CompoundsAzolesThiophenesGlucosidesGlycosidesCarbohydrates

Study Officials

  • Dario Giugliano, MD PHD

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Giugliano, MD

CONTACT

39 081 5665054dario.giugliano@unina2.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Prof of Endocrinology and Metbaolism

Study Record Dates

First Submitted

April 26, 2014

First Posted

May 20, 2014

Study Start

October 1, 2005

Primary Completion

October 1, 2015

Study Completion

January 1, 2017

Last Updated

April 20, 2016

Record last verified: 2015-11

Locations

IT(2)