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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00330330

Enrollment

Registered

2006-05-26

Start date

2003-02-28

Completion date

2006-08-31

Last updated

2008-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Fasting plasma glucose, HbA1c

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.

Interventions

DRUGISIS 113715

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of ISIS 113715	—
To evaluate the pharmacokinetic profile of ISIS 113715	—
To evaluate the pharmacologic activity of ISIS 113715	—

Countries

Poland, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026