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The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISIS-GCGRRx - Dose Level 1 | Experimental | ISIS-GCGRRx - Dose Level 1 |
|
| ISIS-GCGRRx - Dose Level 2 | Experimental | ISIS-GCGRRx - Dose Level 2 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS-GCGRRx- Dose Level 1 | Drug | once weekly dosing for 26 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1C | Change from Baseline | Week 27 and subsequent timepoints |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort | Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo | 50 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Bhanot | Ionis Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ionis Investigational Site | Greenbrae | California | 94904 | United States | ||
| Ionis Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30765435 | Derived | 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. |
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| ISIS-GCGRRx- Dose Level 2 | Drug | once weekly dosing for 26 weeks |
|
|
| Placebo | Drug | once weekly dosing for 26 weeks |
|
| Huntington Park |
| California |
| 90255 |
| United States |
| Ionis Investigational Site | La Mesa | California | 91942 | United States |
| Ionis Investigational Site | Los Angeles | California | 90057 | United States |
| Isis Investigational Site | Spring Valley | California | 91978 | United States |
| Ionis Investigational Site | Port Orange | Florida | 32127 | United States |
| Ionis Investigational Site | Marietta | Georgia | 30060 | United States |
| Ionis Investigational Site | Oxon Hill | Maryland | 20745 | United States |
| Ionis Investigational Site | New York | New York | 10016 | United States |
| Ionis Investigational Site | Greensboro | North Carolina | 27410 | United States |
| Ionis Investigational Site | Morehead City | North Carolina | 28557 | United States |
| Ionis Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Ionis Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Ionis Investigational Site | Eugene | Oregon | 97404 | United States |
| Ionis Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| Ionis Investigational Site | Houston | Texas | 77036 | United States |
| Ionis Investigational Site | Houston | Texas | 77074 | United States |
| Ionis Investigational Site | Katy | Texas | 77450 | United States |
| Ionis Investigational Site | Olympia | Washington | 98502 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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