Status:
WITHDRAWN
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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) versu...
Eligibility Criteria
Inclusion
- Male or female (post-menopausal and/or surgically sterile)
- Aged 18 to 70 years
- Diagnosed with type 2 diabetes mellitus of eight years or less in duration
- Being treated with OAD at stable maximum doses \[defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin\] for at least three months prior to screening
- Having fasting plasma glucose levels of 150-270 mg/dL and HbA1c levels of 7.5-11.0%
Exclusion
- Greater than 3 severe hypoglycemic episodes within six months of screen
- Pregnant, breastfeeding, or intends to become pregnant
- Clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or ALT greater than the upper limit of normal
- Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test
- Patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin \> 200 mg/day
- History of insulin use within three months of screen
- History of diabetic ketoacidosis
- Treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
- History of lactic acidosis while on metformin therapy
- Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
- Clinically significant and currently active diseases
- Clinical significant abnormalities in medical history, physical examination, or laboratory examination
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00327626
Start Date
May 1 2006
End Date
March 1 2007
Last Update
December 5 2022
Active Locations (5)
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1
Soroka Medical Center
Beersheba, Israel, 84101
2
Rambam Medical Center
Haifa, Israel, 31096
3
Western Galilee Medical Center - Nahariya
Nahariya, Israel, 22100
4
Kaplan Medical Center
Rehovot, Israel, 76100