Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 Administered Daily in Patients With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea|
- 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.
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||March 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327626
|Soroka Medical Center|
|BeEr-Sheva, Israel, 84101|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Western Galilee Medical Center - Nahariya|
|Nahariya, Israel, 22100|
|Kaplan Medical Center|
|Rehovot, Israel, 76100|
|Safed, Israel, 13100|
|Study Director:||Mark K Wedel, MD, JD, FACP||Isis Pharmaceuticals|