NCT02824003

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

June 15, 2016

Last Update Submit

May 4, 2018

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Change in fasting hepatic glycogen content

    Change from Baseline

    Week 14

  • Change in fasting hepatic lipid content

    Change from Baseline

    Week 14

Secondary Outcomes (1)

  • Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations

    38 weeks

Study Arms (2)

ISIS-GCGRRx

EXPERIMENTAL

ISIS-GCGRRx once weekly dosing for 13 weeks

Drug: ISIS-GCGRRx

Placebo

PLACEBO COMPARATOR

once weekly dosing for 13 weeks

Drug: Placebo

Interventions

ISIS-GCGRRxDRUG

once weekly dosing for 13 weeks

Also known as: ISIS 449884
ISIS-GCGRRx
PlaceboDRUG

once weekly dosing for 13 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ionis Investigator Site

Vienna, A-1130, Austria

Location

Related Publications (1)

  • Morgan ES, Tai LJ, Pham NC, Overman JK, Watts LM, Smith A, Jung SW, Gajdosik M, Krssak M, Krebs M, Geary RS, Baker BF, Bhanot S. Antisense Inhibition of Glucagon Receptor by IONIS-GCGRRx Improves Type 2 Diabetes Without Increase in Hepatic Glycogen Content in Patients With Type 2 Diabetes on Stable Metformin Therapy. Diabetes Care. 2019 Apr;42(4):585-593. doi: 10.2337/dc18-1343. Epub 2019 Feb 14.

    PMID: 30765435DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sanjay Bhanot

    Ionis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 6, 2016

Study Start

April 1, 2016

Primary Completion

December 15, 2016

Study Completion

May 22, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

AU(1)