AMAZING: Glycemic Durability After Metformin Failure

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Unknown status

CT.gov ID

NCT02142309

Collaborator

(none)

450

Enrollment

Locations

Arms

135

Duration (Months)

225

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Glimepiride Drug: Vildagliptin Drug: Pioglitazone Drug: Canagliflozin	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Oct 1, 2015

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

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

Outcome Measures

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. [Six years]

Secondary Outcome Measures

Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up [6 years]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Geriatrics and Metabolic Diseases	Naples		Italy	80138
2	Katherine Esposito	Naples		Italy	80138

Sponsors and Collaborators

University of Campania "Luigi Vanvitelli"

Investigators

Principal Investigator: Dario Giugliano, MD PHD, University of Campania "Luigi Vanvitelli"

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dario Giugliano, Full Prof of Endocrinology and Metbaolism, University of Campania "Luigi Vanvitelli"

ClinicalTrials.gov Identifier:

NCT02142309

Other Study ID Numbers:

DGM 7-2006

First Posted:

May 20, 2014

Last Update Posted:

Apr 20, 2016

Last Verified:

Nov 1, 2015

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 20, 2016