Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes

May 11, 2015 updated by: Ionis Pharmaceuticals, Inc.

A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada
        • Isis Investigative Site
    • British Columbia
      • Penticton, British Columbia, Canada
        • Isis Investigative Site
    • Ontario
      • Cornwall, Ontario, Canada
        • Isis Investigative Site
      • Courtice, Ontario, Canada
        • Isis Investigative Site
      • Sudbury, Ontario, Canada
        • Isis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2R1V6
        • Isis Investigative Site
  • Romania
      • Bucharest, Romania, 010507
        • Isis Investigative Site
      • Bucharest, Romania, 011794
        • Isis Investigative Site
      • Bucharest, Romania, 022441
        • Isis Investigative Site
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400349
        • Isis Investigative Site
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9300
        • Isis Investigative Site
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • Isis Investigative Site
      • Soweto, Gauteng, South Africa, 1818
        • Isis Investigative Site
    • Western Cape
      • Somerset West, Western Cape, South Africa, 7130
        • Isis Investigative Site

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age 18 to 75
  • BMI greater than or equal to 25
  • HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
  • Type 2 Diabetes Mellitus and on stable dose of oral metformin
  • Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

  • Clinically significant abnormalities in medical history or physical exam
  • Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
  • History of renal transplantation or renal dialysis
  • History of liver disease
  • History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
  • Use of oral anti-diabetic medication other than metformin within 3 months of screening
  • Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
  • History of diabetic ketoacidosis
  • Current or previous diagnosis of Gilbert's disease
  • Any other significant illness or condition that may interfere with the patient participating or completing the study
  • Inability or unwillingness to comply with protocol or study procedures

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Active Comparator: ISIS-GCCRRx
Drug: ISIS-GCCRRx
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of ISIS-GCCRRx on serum fructosamine
Time Frame: 7 Weeks
Change from Baseline to Week 7
7 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of ISIS-GCCRRx
Time Frame: 18 Weeks
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
18 Weeks
The tolerability of ISIS-GCCRRx
Time Frame: 18 Weeks
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
18 Weeks

Collaborators and Investigators

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

Sponsor

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

October 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 426115-CS2
  • 2013-002172-40 (EudraCT Number)

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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