Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
NCT ID: NCT02583919
Last Updated: 2018-06-25
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
79 participants
INTERVENTIONAL
2015-09-30
2017-05-11
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
DOUBLE
Study Groups
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ISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx- Dose Level 1
once weekly dosing for 26 weeks
ISIS-GCGRRx - Dose Level 2
ISIS-GCGRRx - Dose Level 2
ISIS-GCGRRx- Dose Level 2
once weekly dosing for 26 weeks
Placebo
Placebo
Placebo
once weekly dosing for 26 weeks
Interventions
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ISIS-GCGRRx- Dose Level 1
once weekly dosing for 26 weeks
ISIS-GCGRRx- Dose Level 2
once weekly dosing for 26 weeks
Placebo
once weekly dosing for 26 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 25.0 kg/m2
* HbA1c ≥ 8.0% and ≤ 10.5%
* Type 2 Diabetes Mellitus and on stable dose of Metformin
* Agree to conduct home-based (fasted) blood glucose testing as directed
Exclusion Criteria
* Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
* History of solid organ transplant or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Treatment with any other antidiabetic drug(s) other than metformin within 3 months of screening
* History of diabetic ketoacidosis
* 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
75 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjay Bhanot
Role: STUDY_DIRECTOR
Ionis Pharmaceuticals, Inc.
Locations
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Ionis Investigational Site
Greenbrae, California, United States
Ionis Investigational Site
Huntington Park, California, United States
Ionis Investigational Site
La Mesa, California, United States
Ionis Investigational Site
Los Angeles, California, United States
Isis Investigational Site
Spring Valley, California, United States
Ionis Investigational Site
Port Orange, Florida, United States
Ionis Investigational Site
Marietta, Georgia, United States
Ionis Investigational Site
Oxon Hill, Maryland, United States
Ionis Investigational Site
New York, New York, United States
Ionis Investigational Site
Greensboro, North Carolina, United States
Ionis Investigational Site
Morehead City, North Carolina, United States
Ionis Investigational Site
Cincinnati, Ohio, United States
Ionis Investigational Site
Cincinnati, Ohio, United States
Ionis Investigational Site
Eugene, Oregon, United States
Ionis Investigational Site
Spartanburg, South Carolina, United States
Ionis Investigational Site
Houston, Texas, United States
Ionis Investigational Site
Houston, Texas, United States
Ionis Investigational Site
Katy, Texas, United States
Ionis Investigational Site
Olympia, Washington, United States
Countries
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References
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Morgan ES, Tai LJ, Pham NC, Overman JK, Watts LM, Smith A, Jung SW, Gajdosik M, Krssak M, Krebs M, Geary RS, Baker BF, Bhanot S. Antisense Inhibition of Glucagon Receptor by IONIS-GCGRRx Improves Type 2 Diabetes Without Increase in Hepatic Glycogen Content in Patients With Type 2 Diabetes on Stable Metformin Therapy. Diabetes Care. 2019 Apr;42(4):585-593. doi: 10.2337/dc18-1343. Epub 2019 Feb 14.
Other Identifiers
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ISIS 449884-CS4
Identifier Type: -
Identifier Source: org_study_id
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