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

June 20, 2018 updated by: Ionis Pharmaceuticals, Inc.

Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

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
    • California
      • Greenbrae, California, United States, 94904
        • Ionis Investigational Site
      • Huntington Park, California, United States, 90255
        • Ionis Investigational Site
      • La Mesa, California, United States, 91942
        • Ionis Investigational Site
      • Los Angeles, California, United States, 90057
        • Ionis Investigational Site
      • Spring Valley, California, United States, 91978
        • Isis Investigational Site
    • Florida
      • Port Orange, Florida, United States, 32127
        • Ionis Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Ionis Investigational Site
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Ionis Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Ionis Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Ionis Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Ionis Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Ionis Investigational Site
      • Cincinnati, Ohio, United States, 45245
        • Ionis Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Ionis Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Ionis Investigational Site
    • Texas
      • Houston, Texas, United States, 77036
        • Ionis Investigational Site
      • Houston, Texas, United States, 77074
        • Ionis Investigational Site
      • Katy, Texas, United States, 77450
        • Ionis Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Ionis 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 ≥ 25.0 kg/m2
  • HbA1c ≥ 8.0% and ≤ 10.5%
  • Type 2 Diabetes Mellitus and on stable dose of Metformin
  • Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

  • Clinically significant abnormalities in medical history of physical exam
  • Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
  • History of solid organ transplant or renal dialysis
  • History of liver disease
  • History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
  • Treatment with any other antidiabetic drug(s) 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
once weekly dosing for 26 weeks
Experimental: ISIS-GCGRRx - Dose Level 1
Drug: ISIS-GCGRRx- Dose Level 1
once weekly dosing for 26 weeks
Other Names:
  • Isis 449884
Experimental: ISIS-GCGRRx - Dose Level 2
Drug: ISIS-GCGRRx- Dose Level 2
once weekly dosing for 26 weeks
Other Names:
  • Isis 449884

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1C
Time Frame: Week 27 and subsequent timepoints
Change from Baseline
Week 27 and subsequent timepoints

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
Time Frame: 50 weeks
Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo
50 weeks

Collaborators and Investigators

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

Sponsor

Ionis Pharmaceuticals, Inc.

Investigators

  • Study Director: Sanjay Bhanot, 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 (Actual)

September 1, 2015

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

May 11, 2017

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 449884-CS4

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.

Clinical Trials on Type 2 Diabetes

Clinical Trials on ISIS-GCGRRx- Dose Level 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe