Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes
NCT ID: NCT01968265
Last Updated: 2015-05-13
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
38 participants
INTERVENTIONAL
2013-10-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
ISIS-GCCRRx
ISIS-GCCRRx
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Interventions
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ISIS-GCCRRx
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Placebo
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
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
* Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
* History of diabetic ketoacidosis
* Current or previous diagnosis of Gilbert's disease
* 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 Investigative Site
Red Deer, Alberta, Canada
Isis Investigative Site
Penticton, British Columbia, Canada
Isis Investigative Site
Cornwall, Ontario, Canada
Isis Investigative Site
Courtice, Ontario, Canada
Isis Investigative Site
Greater Sudbury, Ontario, Canada
Isis Investigative Site
Montreal, Quebec, Canada
Isis Investigative Site
Bucharest, Bucharest, Romania
Isis Investigative Site
Bucharest, Bucharest, Romania
Isis Investigative site
Bucharest, Bucharest, Romania
Isis Investigative Site
Cluj-Napoca, Cluj, Romania
Isis Investigative Site
Bloemfontein, Free State, South Africa
Isis Investigative Site
Benoni, Gauteng, South Africa
Isis Investigative Site
Soweto, Gauteng, South Africa
Isis Investigative Site
Somerset West, Western Cape, South Africa
Countries
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Other Identifiers
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2013-002172-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISIS 426115-CS2
Identifier Type: -
Identifier Source: org_study_id
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