Status:
COMPLETED
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00330330
Start Date
February 1 2003
End Date
August 1 2006
Last Update
February 6 2008
Active Locations (10)
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1
NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny
Bialystok, Poland, 15-435
2
Prywatna Praktyka Lekarska
Radom, Poland, 26-600
3
Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie
Wołomin, Poland, 05-200
4
Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians
Moscow, Russia, 109125