Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
NCT ID: NCT01885260
Last Updated: 2016-07-04
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
77 participants
INTERVENTIONAL
2013-07-31
2014-11-30
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-GCGRRx Dose Level 1
ISIS-GCGRRx Dose Level 1
ISIS-GCGRRx - Dose Level 1
3 doses on alternate days during the first week and then once weekly for 12 weeks
ISIS-GCGRRx Dose Level 2
ISIS-GCGRRx Dose Level 2
ISIS-GCGRRx - Dose Level 2
3 doses on alternate days during the first week and then once weekly for 12 weeks
Placebo
Placebo
Placebo
3 doses on alternate days during the first week and then once weekly for 12 weeks
Interventions
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ISIS-GCGRRx - Dose Level 1
3 doses on alternate days during the first week and then once weekly for 12 weeks
ISIS-GCGRRx - Dose Level 2
3 doses on alternate days during the first week and then once weekly for 12 weeks
Placebo
3 doses on alternate days during the first week and then once weekly for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI greater than or equal to 25
* HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
* Type 2 Diabetes Mellitus and on stable dose of oral 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 renal transplantation or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Use of oral anti-diabetic medication 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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Locations
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Isis Investigational Site
Birmingham, Alabama, United States
Isis Investigational Site
Muscle Shoals, Alabama, United States
Isis Investigational Site
Anaheim, California, United States
Isis Investigational Site
Chino, California, United States
Isis Investigational Site
Los Angeles, California, United States
Isis Investigational Site
DeLand, Florida, United States
Isis Investigational Site
Fort Lauderdale, Florida, United States
Isis Investigational Site
Miami, Florida, United States
Isis Investigational Site
Marietta, Georgia, United States
Isis Investigational Site
Las Vegas, Nevada, United States
Isis Investigational Site
Cincinnati, Ohio, United States
Isis Investigational Site
Oklahoma City, Oklahoma, United States
Isis Investigational Site
Eugene, Oregon, United States
Isis Investigational Site
Corpus Christi, Texas, United States
Isis Investigational Site
Katy, Texas, United States
Isis Investigational Site
Salt Lake City, Utah, United States
Isis Investigational Site
Renton, Washington, United States
Isis Investigational Site
Spokane, Washington, United States
Isis Investigational Site
Lenasia South, Gauteng, South Africa
Isis Investigational Site
Soweto, Gauteng, South Africa
Isis Investigational Site
Durban, KwaZulu-Natal, South Africa
Isis Investigational Site
Cape Town, Western Cape, South Africa
Isis Investigational Site
Parow, Cape Town, Western Cape, South Africa
Isis Investigational Site
Western Cape, Western Cape, South Africa
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-CS2
Identifier Type: -
Identifier Source: org_study_id
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