Glycemic Durability After Metformin Failure | NCT02142309

Studies
Glycemic Durability After Metformin Failure

NCT02142309

Sponsor

University of Campania Luigi Vanvitelli

Status

Unknown status

Last Update Posted

Apr 20, 2016Estimated

Enrollment

450Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Glimepiride
Vildagliptin
Pioglitazone
Canagliflozin

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Oct 2015Actual

Completion Date

Jan 2017Estimated

First Submitted Date

Apr 26, 2014

First Submission Date that Met QC Criteria

May 15, 2014

First Posted Date

May 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dario Giugliano, Full Prof of Endocrinology and Metbaolism, University of Campania Luigi VanvitelliPrincipal Investigator

Lead Sponsor

University of Campania Luigi VanvitelliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Glimepiride	Drug	Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily	Glimepiride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up		6 years

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dario Giugliano, MD	Contact	39 081 5665054		dario.giugliano@unina2.it

Overall Officials

Name	Affiliation	Role
Dario Giugliano, MD PHD	University of Campania Luigi Vanvitelli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Katherine Esposito	Recruiting	Naples	Naples	80138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C057619	glimepiride
D000077597	Vildagliptin
D000077205	Pioglitazone
D000068896	Canagliflozin

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided