Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Criteria

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