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

Phase 2

Completed

• Conditions: Obese; Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: ISIS-PTP1BRx; Drug: daily OAD (metformin and/or sulfonylurea)

• Registration Number: NCT01918865
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Status Verified: 2014-09
• Primary Completion: 2014-10
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Weekly Dosing for 26 Weeks
ISIS-PTP1BRx	ISIS-PTP1BRx	Weekly Dosing for 26 Weeks
ISIS-PTP1BRx	daily OAD (metformin and/or sulfonylurea)	Weekly Dosing for 26 Weeks
Placebo	daily OAD (metformin and/or sulfonylurea)	Weekly Dosing for 26 Weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Isis Investigational Site; 🇿🇦 Pretoria, South Africa

Isis Investigative Site; 🇨🇦 Toronto, Ontario, Canada