Status:
COMPLETED
Placebo Controlled, Dose Escalation Study in Subjects 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 purpose of this study is to provide an initial assessment of the safety, tolerability and efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.
Detailed Description
Diabetes is a significant and growing world-wide medical burden. Studies have provided unequivocal evidence that improving glycemic control in subjects with diabetes significantly reduces the risk of ...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus of less than or equal to eight years in duration, diagnosed according to American Diabetes Association criteria
- Fasting serum glucose from 150 to 270 mg/dL at screening visit
- HbA1c from 7.5 to 11.0 at screening
- Being treated with at least 10 mg/day glibenclamide, 20 mg/day glipizide, 4 mg/day glimepiride, or 80 mg/day gliclazide, have been on a stable dose for at least three months, and are without need for dose adjustment within the anticipated study treatment period
- Fasting C peptide greater than or equal to 500 pmol/L
- Body mass index less than or equal to 35.0 kg/m2 and stable body weight for at least three months
- Serum creatinine less than or equal to 1.2 mg/dL for females or less than or equal to 1.5 mg/dL for males
Exclusion
- Prior treatment with ISIS 113715
- Undergoing or have undergone treatment with any non marketed, therapeutic agent or device within 90 days prior to screening
- Subjects who have had more than three episodes of severe hypoglycemia within six months (i.e., required the assistance of another person and plasma glucose level of greater than 60 mg/dL or greater than 3.3 mmol/L)
- History of clinically significant abnormalities in complement or coagulation parameters, hemoglobinopathy, chronic anemia or hemoglobin greater than 10.5 mg/dL for females and greater than 11.5 mg/dL for males
- Clinically significant complications of diabetes (e.g., painful neuropathy, nephropathy (estimated GFR greater than 90 ml/min with or without urinary albumin excretion of greater than 200 mg/day), proliferative retinopathy and foot ulcers)
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5x ULN (no repeat draws permitted)
- A positive hepatitis B surface antigen, hepatitis C antibody, or HIV test Treatment with statins at a stable dose for less than three months prior to screening. Simvastatin dosages of up to 40 mg/day are allowed. Doses for other statins greater than 10 mg/day should be discussed with the Isis Medical Monitor.
- Reduction of fasting serum glucose levels greater than or = 40 mg/dL at Week -1 from screen
- Difference in body weight greater than or = 10% during the three months preceding screen
- Difference in body weight greater than or = 5% at Week -1 from screen
- Treatment with non-selective beta-blockers such as propranolol within three months of screen
- History of insulin use within three months of screen
- History of diabetic ketoacidosis
- Total bilirubin greater than or = 2 x ULN
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00455598
Start Date
February 1 2007
End Date
May 1 2009
Last Update
August 28 2009
Active Locations (39)
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1
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Internistyczno
Bialystok, Poland, 15-435
2
Akademickie Centrum Kliniczne- Szpital Akademii Medycznej w Gdańsku
Gdansk, Poland, 80-952
3
Poradnia Neurologiczna i Poradnia
Poznan, Poland, 61-289
4
Niepubliczny Zakład Opieki
Radom, Poland, 26-610