NCT01918865

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 404173 Administered Once Weekly to Obese Patients With Type 2 Diabetes Mellitus Being Treated With Metformin or Metformin Plus Sulfonylurea

Completed Phase 2 Last updated 27 February 2015

What this trial tests

Phase 2 trial testing ISIS-PTP1BRx in Type 2 Diabetes Mellitus in 92 participants. Completed in 1 February 2015.

Timeline

1 August 2013

Primary endpoint
1 October 2014

1 February 2015

Quick facts

Lead sponsor	Ionis Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	92
Start date	1 August 2013
Primary completion	1 October 2014
Estimated completion	1 February 2015
Sites	21 locations across Argentina, Canada, South Africa

Drugs / interventions tested

• ISIS-PTP1BRx — full drug profile →
• Placebo
• daily OAD (metformin and/or sulfonylurea) — full drug profile →

Conditions studied

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

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Type 2 Diabetes Mellitus or Obese. 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.

• Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
  Time frame: 38 weeks
• Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
  Time frame: 27 weeks

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.

Publications & conference data

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

1. Human Protein Tyrosine Phosphatase 1B (PTP1B): From Structure to Clinical Inhibitor Perspectives.
   Liu R, Mathieu C, Berthelet J, Zhang W, et al · · 2022 · cited 81× · PMID 35806030 · DOI 10.3390/ijms23137027
2. 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
3. Recent advances in PTP1B signaling in metabolism and cancer.
   Villamar-Cruz O, Loza-Mejía MA, Arias-Romero LE, Camacho-Arroyo I. · · 2021 · cited 49× · PMID 34726241 · DOI 10.1042/bsr20211994
4. Modulation of VEGF receptor 2 signaling by protein phosphatases.
   Corti F, Simons M. · · 2017 · cited 43× · PMID 27888154 · DOI 10.1016/j.phrs.2016.11.022
5. 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