Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00330330
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- Type 2 Diabetes Mellitus of less than 5 years in duration
- Have never received hypoglycemic therapy
- Aged 18 to 65 years
- Fasting blood glucose between 130 and 220 mg/dL (7.2 to 12.2 mmol/L) for Cohorts A-D and between 140 and 220 mg/dL (7.8 to 12.2 mmol/L) for Cohort E
- HbA1c between 6.8 and 10.0% for Cohorts A-D and between 7.5 and 11.0% for Cohort E
- Body Mass index > 25 and < 35 kg m -2
- Medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
- Clinically significant abnormalities in medical history or physical exam
- Clinically significant abnormalities on laboratory examination
- History of HIV infection
- Active infection requiring antiviral or antimicrobial therapy
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year at the time of screening)
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in or interfere with compliance
- Alcohol or drug abuse
- Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening
- Abnormal serum creatinine concentration defined as > 1.5 mg/dL (132.6 micro mol/L) for males and > 1.2 mg/dL (106 micro mol/L) for females
- Medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.
- Allergy to sulfur-containing medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the pharmacokinetic profile of ISIS 113715 To evaluate the safety and tolerability of ISIS 113715 To evaluate the pharmacologic activity of ISIS 113715
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Close Corporation "MEDSI"
🇷🇺Moscow, Russian Federation
NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny
🇵🇱Bialystok, Poland
Prywatna Praktyka Lekarska
🇵🇱Radom, Poland
Clinic of Therapy of Postgraduate Education named after N.S. Molchanov
🇷🇺St. Petersburg, Russian Federation
Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie
🇵🇱Wolomin, Poland
Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians
🇷🇺Moscow, Russian Federation
Endocrinology Scientific Centre of RAMS
🇷🇺Moscow, Russian Federation
Medical Institution "Polyclinic OAOA Gazprom"
🇷🇺Moscow, Russian Federation
Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky
🇷🇺Moscow, Russian Federation
Chair of Endocrinology and Diabetology Central Clinical Hospital of the Ministry of Communications of RF
🇷🇺Moscow, Russian Federation