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Glycemic Durability After Metformin Failure (AMAZING)

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Glimepiride
Vildagliptin
Pioglitazone
Canagliflozin
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Geriatrics and Metabolic Diseases
  • Katherine EspositoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Glimepiride

Vildagliptin

Pioglitazone

Canagliflozin

Arm Description

up to 4 mg/day

50 mg bid

up to 30 mg/day

300 mg/day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2014
Last Updated
April 19, 2016
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT02142309
Brief Title
Glycemic Durability After Metformin Failure
Acronym
AMAZING
Official Title
Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glimepiride
Arm Type
Experimental
Arm Description
up to 4 mg/day
Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
50 mg bid
Arm Title
Pioglitazone
Arm Type
Experimental
Arm Description
up to 30 mg/day
Arm Title
Canagliflozin
Arm Type
Experimental
Arm Description
300 mg/day
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Description
Reduce to 50 mg if estimated glomerular filtration rate (eGFR) <45 mL/min
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Start with 15 mg/day and advance to 30 mg/day
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Intervention Description
Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up
Time Frame
6 years
Other Pre-specified Outcome Measures:
Title
Changes of low density lipoprotein cholesterol level from baseline each year of follow up
Time Frame
6 years
Title
Changes of high density lipoprotein cholesterol level from baseline each year of follow up
Time Frame
six years
Title
Changes of triglyceride level from baseline each year of follow up
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dario Giugliano, MD
Phone
39 081 5665054
Email
dario.giugliano@unina2.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Giugliano, MD PHD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Geriatrics and Metabolic Diseases
City
Naples
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Katherine Esposito
City
Naples
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Ida Maiorino, MD
Email
mariaida.maiorino@unina2.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Bellastella, MD

12. IPD Sharing Statement

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Glycemic Durability After Metformin Failure

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