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

February 27, 2015 updated by: Ionis Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Isis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVD
        • Isis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Isis Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
        • Isis Investigational Site
      • Vancouver, British Columbia, Canada, V6J 1S3
        • Isis Investigational Site
    • Ontario
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Isis Investigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Isis Investigational Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Isis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Isis Investigational Site
  • South Africa
      • Benoni, South Africa, 1500
        • Isis Investigational Site
      • Bloemfontein, South Africa, 9301
        • Isis Investigational Site
      • Pretoria, South Africa, 0184
        • Isis Investigational Site
    • Gauteng
      • Centurion, Gauteng, South Africa, 0154
        • Isis Investigational Site
      • Mamelodi, Gauteng, South Africa, 0122
        • Isis Investigational Site
      • Pretoria, Gauteng, South Africa, 0001
        • Isis Investigational Site
    • Korsten
      • Port Elizabeth, Korsten, South Africa
        • Isis Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
        • Isis Investigational Site
    • Mpumalanga
      • Middelburg, Mpumalanga, South Africa
        • Isis Investigational Site
    • Thabazimbi
      • Limpopo, Thabazimbi, South Africa, 0380
        • Isis Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Isis Investigational Site
      • Cape Town, Western Cape, South Africa
        • Isis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ISIS-PTP1BRx
Weekly Dosing for 26 Weeks
Drug: ISIS-PTP1BRx
Drug: daily OAD (metformin and/or sulfonylurea)
Placebo Comparator: Placebo
Weekly Dosing for 26 Weeks
Drug: Placebo
Drug: daily OAD (metformin and/or sulfonylurea)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: 27 Weeks
27 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 404173-CS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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