Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics

December 1, 2022 updated by: Ionis Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of ISIS 113715 Monotherapy on Insulin Sensitivity, Glucose and Lipid Metabolism and Energy Expenditure in Subjects With Type 2 Diabetes Mellitus

The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale - New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female (post menopausal and/or surgically sterile)
  • Aged 18 to 70 years
  • Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of >/= 35% and HbA1c levels of >/= 7% and </= 10.0%
  • Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of >/= 35%, and HbA1c levels of >/= 6.5% and </= 9.0%

Exclusion Criteria:

  • Greater than 3 severe hypoglycemic episodes within six months of screen
  • Pregnant, breastfeeding, or intends to become pregnant
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5 times the upper limit of normal
  • History of hepatitis B surface antigen, hepatitis C antibody, or HIV
  • Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
  • Clinically significant and currently active diseases
  • Clinically significant abnormalities in medical history, physical examination, or laboratory examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Examine the effect on whole body energy expenditure
Evaluate the effects on fasting and postprandial glucose excursions
Evaluate the effects on hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Outcome Measure
Expand the safety and tolerability profile for ISIS 113715
Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Investigators

  • Study Chair: Isis Pharmaceuticals, Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (ESTIMATE)

May 26, 2006

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 113715-CS11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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