NCT01968265 is a Phase 2 clinical trial of ISIS-GCCRRx in Type 2 Diabetes Mellitus, sponsored by Ionis Pharmaceuticals, Inc..

Who is sponsoring NCT01968265?

NCT01968265 is sponsored by Ionis Pharmaceuticals, Inc..

What drugs are being tested in NCT01968265?

Interventions in NCT01968265: ISIS-GCCRRx, Placebo.

What condition does NCT01968265 study?

NCT01968265 studies Type 2 Diabetes Mellitus.

Is NCT01968265 still recruiting?

NCT01968265 is currently completed. Last updated 11 May 2015.

Last reviewed 2015-05-11 · How we verify

NCT01968265

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 11 May 2015

What this trial tests

Phase 2 trial testing ISIS-GCCRRx in Type 2 Diabetes Mellitus in 38 participants. Completed in 1 May 2015.

Timeline

1 October 2013

Primary endpoint
1 January 2015

1 May 2015

Quick facts

Lead sponsor	Ionis Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	38
Start date	1 October 2013
Primary completion	1 January 2015
Estimated completion	1 May 2015
Sites	14 locations across Canada, Romania, South Africa

Drugs / interventions tested

ISIS-GCCRRx — full drug profile →
Placebo

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The effect of ISIS-GCCRRx on serum fructosamine
Time frame: 7 Weeks
Change from Baseline to Week 7

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Antisense technology: A review.
Crooke ST, Liang XH, Baker BF, Crooke RM. · · 2021 · cited 237× · PMID 33600796 · DOI 10.1016/j.jbc.2021.100416
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
Antisense Oligonucleotides: Technological Advances, Clinical Progress, and Expanding Therapeutic Frontiers.
Xu L, Zhang H, Jiang B, Jiang Y, et al · · 2026 · PMID 42076098 · DOI 10.3390/pharmaceutics18040446

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Ionis Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01968265 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
Last refreshed: 11 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01968265.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing