Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
Phase 2
Withdrawn
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00327626
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- 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) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Rambam Medical Center
🇮🇱Haifa, Israel
Western Galilee Medical Center - Nahariya
🇮🇱Nahariya, Israel
Soroka Medical Center
🇮🇱BeEr-Sheva, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
ZIV Hospital
🇮🇱Safed, Israel