| Trial ID: | L3049 |
| Source ID: | NCT00327626
|
| Associated Drug: |
Isis 113715
|
| Title: |
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ISIS 113715
|
| Outcome Measures: |
Primary: Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.|Examine the effect of treatment with 15 and 30 mg/day ISIS 113715 on fasting plasma glucose and HbA1c.|Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin. |
|
| Sponsor/Collaborators: |
Sponsor: Ionis Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-05-01
|
| Completion Date: |
2007-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-12-05
|
| Locations: |
Soroka Medical Center, BeEr-Sheva, 84101, Israel|Rambam Medical Center, Haifa, 31096, Israel|Western Galilee Medical Center - Nahariya, Nahariya, 22100, Israel|Kaplan Medical Center, Rehovot, 76100, Israel|ZIV Hospital, Safed, 13100, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT00327626
|
