Glycemic Durability After Metformin Failure

Type 2 Diabetes Clinical Trial

— AMAZING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02142309
• Other study ID #: DGM 7-2006
• Status: Recruiting
• Phase: Phase 4
• First received: April 26, 2014
• Last updated: April 19, 2016
• Start date: October 2005
• Est. completion date: January 2017

Study information

• Verified date: November 2015
• Source: Second University of Naples
• Contact: Dario Giugliano, MD
• Phone: 39 081 5665054
• Email: dario.giugliano[@]unina2.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Geriatrics and Metabolic Diseases	Naples
Italy	Katherine Esposito	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of low density lipoprotein cholesterol level from baseline each year of follow up		6 years	Yes
Other	Changes of high density lipoprotein cholesterol level from baseline each year of follow up		six years	Yes
Other	Changes of triglyceride level from baseline each year of follow up		6 years	Yes
Primary	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	Yes
Secondary	Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up		6 years	Yes