Clinical Trial Details
| Trial ID: | L6292 |
| Source ID: | NCT02484209 |
| Associated Drug: | Metformin |
| Title: | DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study) |
| Acronym: | DiaFrail |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus |
| Interventions: | DRUG: Metformin|DRUG: Glimepiride|DRUG: Metformin |
| Outcome Measures: | Primary: Difference in hypoglycaemia occurrence (mild-moderate category) between treatment arms, The primary objective of this short PILOT study will be the evaluation of the difference (as % of variation of mild-moderate hypoglycaemic events) between the treatment arms, 16 weeks | Secondary: Duration of Hypoglycaemia, Duration in minutes with glucose less \<54 mg/dl (3 mmol/l) during a 24-h period, week 1|Duration of Hypoglycaemia, Duration in minutes with glucose less \<54 mg/dl (3 mmol/l) during a 24-h period, week 8|Duration of Hypoglycaemia, Duration in minutes with glucose less \<54 mg/dl (3 mmol/l) during a 24-h period, week 16 |
| Sponsor/Collaborators: | Sponsor: Diabetes Frail Ltd | Collaborators: Merck Sharp & Dohme LLC|University of Campania Luigi Vanvitelli |
| Gender: | ALL |
| Age: | OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 0 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH |
| Start Date: | 2016-02 |
| Completion Date: | 2016-11 |
| Results First Posted: | |
| Last Update Posted: | 2017-07-28 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT02484209 |
