Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes

May 4, 2018 updated by: Ionis Pharmaceuticals, Inc.

Double Blind, Randomized, Placebo-Controlled, Phase 2A Mechanistic Study to Evaluate the Effect of ISIS 449884 (ISIS-GCGRRx) on Hepatic Lipid and Glycogen Content in Patients With Type 2 Diabetes Being Treated With Metformin

The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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

  • Austria
      • Vienna, Austria, A-1130
        • Ionis Investigator 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 < 36.0 kg/m2
  • HbA1c ≥ 7.5% and ≤ 10.5%
  • Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed
  • 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
  • History of liver transplantation 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, SU or DPPIV 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ISIS-GCGRRx
ISIS-GCGRRx once weekly dosing for 13 weeks
Drug: ISIS-GCGRRx
once weekly dosing for 13 weeks
Other Names:
  • ISIS 449884
PLACEBO_COMPARATOR: Placebo
once weekly dosing for 13 weeks
Drug: Placebo
once weekly dosing for 13 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting hepatic glycogen content
Time Frame: Week 14
Change from Baseline
Week 14
Change in fasting hepatic lipid content
Time Frame: Week 14
Change from Baseline
Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations
Time Frame: 38 weeks
Safety results in patients dosed with ISIS 449884 will be compared with those from patients dosed with placebo
38 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

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)

April 1, 2016

Primary Completion (ACTUAL)

December 15, 2016

Study Completion (ACTUAL)

May 22, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (ESTIMATE)

July 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 449884-CS3

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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