Trials / Completed
CompletedNCT03278158
A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2
A Single-dose Dose Escalation Trial in a Randomised, Single-blind, Placebo-controlled Group-comparison Design to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Pila Pharma · Industry
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-dose dose escalation trial in a randomised, single-blind, placebo-controlled group-comparison design to investigate the safety and tolerability of XEN-D0501 in subjects with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Subjects in the placebo arm will receive a single oral tablet containing no active drug. |
| DRUG | XEN-D0501, 1 mg/tablet | Subjects in this arm will receive a single oral tablet of XEN-D0501, 1 mg/tablet |
| DRUG | XEN-D0501, 2 mg/tablet | Subjects in this arm will receive a single oral tablet of XEN-D0501, 2 mg/tablet |
| DRUG | XEN-D0501, 4 mg/tablet | Subjects in this arm will receive a single oral tablet of XEN-D0501, 4 mg/tablet |
| DRUG | XEN-D0501, 8 mg/tablet | Subjects in this arm will receive a single oral tablet of XEN-D0501, 8 mg/tablet |
Timeline
- Start date
- 2017-09-18
- Primary completion
- 2018-11-13
- Completion
- 2018-11-13
- First posted
- 2017-09-11
- Last updated
- 2019-03-22
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03278158. Inclusion in this directory is not an endorsement.