Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea

Ionis Pharmaceuticals

Status and phase

Withdrawn

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: ISIS 113715

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327626

ISIS 113715-CS12

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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