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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ISIS 113715

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No