Glycemic Durability After Metformin Failure (AMAZING)

University of Campania "Luigi Vanvitelli"

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Vildagliptin; Drug: Glimepiride; Drug: Pioglitazone; Drug: Canagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT02142309

DGM 7-2006

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 4 patient groups

Glimepiride

Experimental group

Description:

up to 4 mg/day

Treatment:

Drug: Glimepiride

Vildagliptin

Experimental group

Description:

50 mg bid

Treatment:

Drug: Vildagliptin

Pioglitazone

Experimental group

Description:

up to 30 mg/day

Treatment:

Drug: Pioglitazone

Canagliflozin

Experimental group

Description:

300 mg/day

Treatment:

Drug: Canagliflozin