Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes
NCT ID: NCT01918865
Last Updated: 2015-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2013-08-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ISIS-PTP1BRx
Weekly Dosing for 26 Weeks
ISIS-PTP1BRx
daily OAD (metformin and/or sulfonylurea)
Placebo
Weekly Dosing for 26 Weeks
Placebo
daily OAD (metformin and/or sulfonylurea)
Interventions
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ISIS-PTP1BRx
Placebo
daily OAD (metformin and/or sulfonylurea)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Isis Investigative Site
Mar del Plata, Buenos Aires, Argentina
Isis Investigative Site
Rosario, Santa Fe Province, Argentina
Isis Investigational Site
Edmonton, Alberta, Canada
Isis Investigational Site
Kelowna, British Columbia, Canada
Isis Investigational Site
Vancouver, British Columbia, Canada
Isis Investigational Site
Etobicoke, Ontario, Canada
Isis Investigational Site
Toronto, Ontario, Canada
Isis Investigative Site
Toronto, Ontario, Canada
Isis Investigational Site
Saskatoon, Saskatchewan, Canada
Isis Investigational Site
Benoni, Benoni, South Africa
Isis Investigational Site
Bloemfontein, Bloemfontein, South Africa
Isis Investigational Site
Centurion, Gauteng, South Africa
Isis Investigational Site
Mamelodi, Gauteng, South Africa
Isis Investigational Site
Pretoria, Gauteng, South Africa
Isis Investigational Site
Port Elizabeth, Korsten, South Africa
Isis Investigational Site
Durban, KwaZulu-Natal, South Africa
Isis Investigational Site
Middelburg, Mpumalanga, South Africa
Isis Investigational Site
Pretoria, Pretoria, South Africa
Isis Investigational Site
Limpopo, Thabazimbi, South Africa
Isis Investigational Site
Cape Town, Western Cape, South Africa
Isis Investigational Site
Cape Town, Western Cape, South Africa
Countries
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References
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Digenio A, Pham NC, Watts LM, Morgan ES, Jung SW, Baker BF, Geary RS, Bhanot S. Antisense Inhibition of Protein Tyrosine Phosphatase 1B With IONIS-PTP-1BRx Improves Insulin Sensitivity and Reduces Weight in Overweight Patients With Type 2 Diabetes. Diabetes Care. 2018 Apr;41(4):807-814. doi: 10.2337/dc17-2132. Epub 2018 Feb 9.
Other Identifiers
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ISIS 404173-CS2
Identifier Type: -
Identifier Source: org_study_id
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