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
1 other identifier
interventional
92
3 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Aug 2013
Typical duration for phase_2 type-2-diabetes-mellitus
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 5, 2013
CompletedFirst Posted
Study publicly available on registry
August 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 3, 2015
September 1, 2014
1.2 years
August 5, 2013
February 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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
Study Arms (2)
ISIS-PTP1BRx
EXPERIMENTALWeekly Dosing for 26 Weeks
Placebo
PLACEBO COMPARATORWeekly Dosing for 26 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Isis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN, Argentina
Isis Investigative Site
Rosario, Santa Fe Province, 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
Benoni, Benoni, 1500, South Africa
Isis Investigational Site
Bloemfontein, Bloemfontein, 9301, South Africa
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
Pretoria, Pretoria, 0184, 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
Related Publications (1)
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.
PMID: 29439147DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2013
First Posted
August 8, 2013
Study Start
August 1, 2013
Primary Completion
October 1, 2014
Study Completion
February 1, 2015
Last Updated
March 3, 2015
Record last verified: 2014-09