Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Isis Pharmaceuticals |
---|---|
Information provided by: | Isis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00327626 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: ISIS 113715 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 96 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | March 2008 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Rambam Medical Center | |
Haifa, Israel, 31096 | |
Western Galilee Medical Center - Nahariya | |
Nahariya, Israel, 22100 | |
ZIV Hospital | |
Safed, Israel, 13100 | |
Kaplan Medical Center | |
Rehovot, Israel, 76100 | |
Soroka Medical Center | |
BeEr-Sheva, Israel, 84101 |
Study Director: | Mark K Wedel, MD, JD, FACP | Isis Pharmaceuticals |
Study ID Numbers: | ISIS 113715-CS12 |
Study First Received: | May 16, 2006 |
Last Updated: | May 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00327626 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Fasting plasma glucose HbA1c Oral antidiabetic agent(s) |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |