| Trial ID: | L4276 |
| Source ID: | NCT03278158
|
| Associated Drug: |
Placebo
|
| Title: |
A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: XEN-D0501, 1 mg/tablet|DRUG: XEN-D0501, 2 mg/tablet|DRUG: XEN-D0501, 4 mg/tablet|DRUG: XEN-D0501, 8 mg/tablet
|
| Outcome Measures: |
Primary: Safety and tolerability of single ascending oral doses of XEN-D0501, (1, 2, 4 and 8 mg) versus placebo in type 2 diabetic patients in treatment with metformin (Incidence of adverse events in type 2 diabetic patients), Incidence of adverse events in type 2 diabetic patients, 1-3 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Pila Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
26
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-18
|
| Completion Date: |
2018-11-13
|
| Results First Posted: |
|
| Last Update Posted: |
2019-03-22
|
| Locations: |
Odense University Hospital, Odense, 5000, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT03278158
|
