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Clinical Trial Details

Trial ID: L3113
Source ID: NCT01918865
Associated Drug: Isis-Ptp1brx
Title: Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Obese
Interventions: DRUG: ISIS-PTP1BRx|DRUG: Placebo|DRUG: daily OAD (metformin and/or sulfonylurea)
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Ionis Pharmaceuticals, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 92
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-08
Completion Date: 2015-02
Results First Posted:
Last Update Posted: 2015-03-03
Locations: Isis Investigative Site, Mar del Plata, Buenos Aires, B7600FZN, Argentina|Isis Investigative Site, Rosario, Santa Fe, S2000CVD, Argentina|Isis Investigational Site, Edmonton, Alberta, T6G 2E1, Canada|Isis Investigational Site, Kelowna, British Columbia, V1Y 3G8, Canada|Isis Investigational Site, Vancouver, British Columbia, V6J 1S3, Canada|Isis Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Isis Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Isis Investigative Site, Toronto, Ontario, M9V 4B4, Canada|Isis Investigational Site, Saskatoon, Saskatchewan, S7K 3H3, Canada|Isis Investigational Site, Centurion, Gauteng, 0154, South Africa|Isis Investigational Site, Mamelodi, Gauteng, 0122, South Africa|Isis Investigational Site, Pretoria, Gauteng, 0001, 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, Limpopo, Thabazimbi, 0380, South Africa|Isis Investigational Site, Cape Town, Western Cape, 7570, South Africa|Isis Investigational Site, Cape Town, Western Cape, South Africa|Isis Investigational Site, Benoni, 1500, South Africa|Isis Investigational Site, Bloemfontein, 9301, South Africa|Isis Investigational Site, Pretoria, 0184, South Africa
URL: https://clinicaltrials.gov/show/NCT01918865

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress