NCT00330330CompletedPhase 2
A Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 in Patients With Type 2 Diabetes Mellitus Who Have Not Received Prior Therapy
Ionis Pharmaceuticals, Inc.20 sites in 3 countries96 target enrollmentStarted: February 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ionis Pharmaceuticals, Inc.
- Enrollment
- 96
- Locations
- 20
- Primary Endpoint
- To evaluate the pharmacokinetic profile of ISIS 113715
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (20)
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