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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 + metformin
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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 | 3 doses on alternate days during the first week and then once weekly for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of ISIS-GCGRRx on serum fructosamine | Change from Baseline to Week 14 | 14 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of ISIS-GCGRRx | By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations | 25 Weeks |
| The tolerability of ISIS-GCGRRx | By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isis Investigational Site | Birmingham | Alabama | 35216 | United States | ||
| Isis 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 | 3 doses on alternate days during the first week and then once weekly for 12 weeks |
|
|
| Placebo | Drug | 3 doses on alternate days during the first week and then once weekly for 12 weeks |
|
| 25 Weeks |
| Muscle Shoals |
| Alabama |
| 35662 |
| United States |
| Isis Investigational Site | Anaheim | California | 92801 | United States |
| Isis Investigational Site | Chino | California | 91710 | United States |
| Isis Investigational Site | Los Angeles | California | 90057 | United States |
| Isis Investigational Site | DeLand | Florida | 32720 | United States |
| Isis Investigational Site | Fort Lauderdale | Florida | 33306 | United States |
| Isis Investigational Site | Miami | Florida | 33143 | United States |
| Isis Investigational Site | Marietta | Georgia | 30066 | United States |
| Isis Investigational Site | Las Vegas | Nevada | 89101 | United States |
| Isis Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Isis Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Isis Investigational Site | Eugene | Oregon | 97404 | United States |
| Isis Investigational Site | Corpus Christi | Texas | 78404 | United States |
| Isis Investigational Site | Katy | Texas | 77450 | United States |
| Isis Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Isis Investigational Site | Renton | Washington | 98057 | United States |
| Isis Investigational Site | Spokane | Washington | 99202 | United States |
| Isis Investigational Site | Lenasia South | Gauteng | 1829 | South Africa |
| Isis Investigational Site | Soweto | Gauteng | 1818 | South Africa |
| Isis Investigational Site | Durban | KwaZulu-Natal | 4091 | South Africa |
| Isis Investigational Site | Cape Town | Western Cape | 7700 | South Africa |
| Isis Investigational Site | Parow, Cape Town | Western Cape | 7500 | South Africa |
| Isis Investigational Site | Western Cape | Western Cape | 7130 | South Africa |
| 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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