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

June 30, 2016 updated by: Ionis Pharmaceuticals, Inc.

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly 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-GCGRRx in combination with metformin versus placebo + metformin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

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

  • South Africa
      • Western Cape, South Africa, 7130
        • Isis Investigational Site
    • Gauteng
      • Lenasia South, Gauteng, South Africa, 1829
        • Isis Investigational Site
      • Soweto, Gauteng, South Africa, 1818
        • Isis Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Isis Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Isis Investigational Site
      • Parow, Cape Town, Western Cape, South Africa, 7500
        • Isis Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Isis Investigational Site
      • Muscle Shoals, Alabama, United States, 35662
        • Isis Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Isis Investigational Site
      • Chino, California, United States, 91710
        • Isis Investigational Site
      • Los Angeles, California, United States, 90057
        • Isis Investigational Site
    • Florida
      • Deland, Florida, United States, 32720
        • Isis Investigational Site
      • Ft. Lauderdale, Florida, United States, 33306
        • Isis Investigational Site
      • Miami, Florida, United States, 33143
        • Isis Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30066
        • Isis Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Isis Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Isis Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Isis Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Isis Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Isis Investigational Site
      • Katy, Texas, United States, 77450
        • Isis Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Isis Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Isis Investigational Site
      • Spokane, Washington, United States, 99202
        • Isis Investigational 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
  • History of diabetic ketoacidosis
  • 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: Parallel Assignment
  • Masking: Triple

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 12 weeks
Experimental: ISIS-GCGRRx Dose Level 1
Drug: ISIS-GCGRRx - Dose Level 1
3 doses on alternate days during the first week and then once weekly for 12 weeks
Other Names:
  • Isis 449884
Experimental: ISIS-GCGRRx Dose Level 2
Drug: ISIS-GCGRRx - Dose Level 2
3 doses on alternate days during the first week and then once weekly for 12 weeks
Other Names:
  • Isis 449884

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of ISIS-GCGRRx on serum fructosamine
Time Frame: 14 Weeks
Change from Baseline to Week 14
14 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of ISIS-GCGRRx
Time Frame: 25 Weeks
By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
25 Weeks
The tolerability of ISIS-GCGRRx
Time Frame: 25 Weeks
By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
25 Weeks

Collaborators and Investigators

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

Sponsor

Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 4, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 449884-CS2

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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