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

Ionis Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: ISIS 113715

Study type

Interventional

Funder types

Industry

Identifiers

NCT00330330

ISIS 113715-CS7

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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