Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01918865

Enrollment

Registered

2013-08-08

Start date

2013-08-31

Completion date

2015-02-28

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, T2DM

Brief summary

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.

Interventions

DRUGISIS-PTP1BRx

DRUGPlacebo

DRUGdaily OAD (metformin and/or sulfonylurea)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Body mass index (BMI) \>/= 27 kg/m2 * HbA1c between 7.5% and 10.5% (inclusive) * C-Peptide (fasting) greater than or equal to 500 pmol/L * On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for \>/= 3 months prior to screening, and remain on stable dose throughout the study * Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion criteria

* Clinically significant abnormalities in medical history or physical exam * Serum creatinine \> ULN at Screening * Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST \> 1.5x ULN at Screening * History of renal transplantation or renal dialysis * GFR \< 60 mL/min at Screening * History of diabetic ketoacidosis * History of greater than 3 episodes of severe hypoglycemia within 6 months of screening * Allergy to sulfur containing drugs * Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines * 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy	27 Weeks

Countries

Argentina, Canada, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026