| Trial ID: | L5778 |
| Source ID: | NCT02142309
|
| Associated Drug: |
Glimepiride
|
| Title: |
Glycemic Durability After Metformin Failure
|
| Acronym: |
AMAZING
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Glimepiride|DRUG: Vildagliptin|DRUG: Pioglitazone|DRUG: Canagliflozin
|
| Outcome Measures: |
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 | Secondary: Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up, 6 years | Other: 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
|
| Sponsor/Collaborators: |
Sponsor: University of Campania Luigi Vanvitelli
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
450
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-10
|
| Completion Date: |
2017-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-20
|
| Locations: |
Department of Geriatrics and Metabolic Diseases, Naples, 80138, Italy|Katherine Esposito, Naples, 80138, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02142309
|
