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| Name | Class |
|---|---|
| REMD Biotherapeutics, Inc. | INDUSTRY |
| Juvenile Diabetes Research Foundation | OTHER |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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A pilot study for individuals with Type 1 Diabetes who are willing to add an SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor) in combination with placebo or a GRA (Glucagon Receptor Antagonist) to their current diabetes treatment regimen. There will be 15 study visits over approximately 14 weeks in this cross-over study design. Treatment "A" consists of an SGLT-2i + GRA for 4 weeks and treatment "B" consists of an SGLT-2i + placebo for 4 weeks. All participants will complete both treatment "A" and treatment "B" with a 6-week washout period in between the treatments. Testing includes 3 insulin withdraw challenges, 3 muscle biopsies, 3 fat biopsies, 3 vascular ultrasounds along with blood collection and vitals.
This is a single-center, randomized, double-blind, cross-over, multi-dose study designed to elicit pilot data for a larger project. To accomplish the specific aims proposed, a single clinical trial will be conducted in which a maximum of 12 subjects with T1D, who are otherwise healthy, will be treated with an oral SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor), 10mg dapagliflozin taken daily in combination with a GRA (Glucagon Receptor Antagonist), 70mg REMD-477 subcutaneous injection once a week or placebo (subcutaneous injection to match the volume of REMD-477) once a week. There will be two treatments: Treatment "A" consists of an SGLT-2i + GRA for 4 weeks and Treatment "B" consists of an SGLT-2i + placebo for 4 weeks. Participants will be randomly assigned to either start with Treatment A or Treatment B for the first 4 weeks of treatment. After completing the first treatment group, participants will be washed off all study drug for 6 weeks. After the washout period, participants will complete 4 weeks of dosing with the opposite treatment they received during the first 4 weeks.
There will be 15 study visits as outlined below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Daily, Oral,10mg dapagliflozin in combination with Weekly, Subcutaneous, 35mg in 1mL solution REMD-477 |
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| Treatment B | Placebo Comparator | Daily, Oral,10mg dapagliflozin in combination with Weekly, Subcutaneous, 1mL solution Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 MG [Farxiga] | Drug | 4-Week, double-blind, once daily oral 10mg dapagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beta-hydroxybutyrate (BHB) Level | The change from baseline in peak BHB production as measured by the insulin withdrawal challenge. | 4-Weeks |
| Change in Glycemic Control | The change from baseline glycemic control as measured by a 2-week average of CGM "time-in-range". | 4-Weeks |
| Change in Glycemic Control | The change from baseline glycemic control as measured by HbA1c. | 4-Weeks |
| Change in Vascular Endothelial Function | The change from baseline in vascular endothelial function as measured by flow mediated dilation (brachial artery diameter). | 4-Weeks |
| Change in Vascular Endothelial Function | The change from baseline in vascular endothelial function as measured by reactive hyperemia-peripheral arterial tonometry (reactive hyperemia index). | 4-Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Altman Clinical & Translational Research Institute | La Jolla | California | 92037 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2023 | Mar 1, 2023 | 7 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C000629677 | volagidemab |
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Single-center, randomized, double-blind, cross-over, multi-dose study.
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Double-blind
| REMD-477 | Drug | 4-Week, double-blind, once weekly subcutaneous injection with 35mg REMD-477 in 1mL solution. |
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| Placebo | Drug | 4-Week, double-blind, once weekly subcutaneous injection with placebo in 1mL solution. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |