| Trial ID: | L2269 |
| Source ID: | NCT00836225
|
| Associated Drug: |
Isis 388626
|
| Title: |
Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ISIS 388626
|
| Outcome Measures: |
Primary: To evaluate the safety and tolerability of single and multiple doses of ISIS-SGLT2Rx administered subcutaneously, 30 days for single dose, 11 weeks for 6-week dosing, 18 weeks for 13-week dosing | Secondary: Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups, 3 days for single dose, 11 weeks for 6-week dosing, 18 weeks for 13-week dosing
|
| Sponsor/Collaborators: |
Sponsor: Ionis Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
103
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01
|
| Completion Date: |
2012-01
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-03
|
| Locations: |
Center for Human Drug Research, Leiden, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00836225
|
