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| ID | Type | Description | Link |
|---|---|---|---|
| 1987 | Other Identifier | Diabetes and Endocrinology Research Foundation |
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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
| Juvenile Diabetes Research Foundation | OTHER |
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To assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.
This will be a 52 week study for type 1 diabetics looking into the effect of semaglutide and dapagliflozin on HbA1c and glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard of care insulin will be used as an active comparator arm for 1/3 of patients (38 patients) for the entire duration of the study. |
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| Dual Therapy | Experimental | Once a week injection of Semaglutide (a GLP-1 receptor agonist) in addition to standard of care insulin for the first six months in 2/3 of patients (76 patients). Semaglutide is a clear, colorless solution that contains 2 mg of semaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector. Semaglutide will be started at the 0.25 mg dose for the first two weeks, then increased to 0.5 mg at week 2, and then yet again increased to 1.0 mg at week 4. |
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| Triple therapy | Experimental | Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of Dapagliflozin (an SGLT-2 inhibitor) added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)). Dapagliflozin will be started at 5 mg for one week, and then increased to 10 mg for the remainder of the study |
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| Triple therapy control | Placebo Comparator | Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of the Placebo form of Dapagliflozin added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Standard of care insulin for pump or injection and serves as a control |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c following dapagliflozin | Change in HbA1c at 6 months following dapagliflozin or placebo therapy in addition to combined semaglutide and insulin treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c with triple therapy | Change in HbA1c from baseline at 12 months in triple therapy group compared to insulin only group. | 12 months |
| Change in HbA1c with semaglutide | Change in HbA1c from baseline at 6 months in dual therapy group (insulin and semaglutide) compared to insulin only group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Husam Ghanim, PhD | State University of NY at Buffalo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes and Endocrinology Research Center of WNY | Williamsville | New York | 14221 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2019 | Mar 27, 2019 | Prot_000.pdf |
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| 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 |
|---|---|
| D007328 | Insulin |
| C000591245 | semaglutide |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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This will be a two-center, randomized, open-label then double-blind, parallel group, placebo and standard of care controlled prospective study in type 1 diabetes.
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This will be a two-center, randomized, open-label then double-blind, parallel group, placebo and standard of care controlled prospective study in type 1 diabetes.
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| Semaglutide | Drug | Injectable weekly GLP-1RA given as open label experimental drug |
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| Dapagliflozin | Drug | Oral daily SGLT2 Inhibitor given as experimental drug |
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| Placebo to Dapagliflozin | Drug | Placebo to Dapagliflozin given as a control to the experimental drug |
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| 6 months |
| Assessment of hyperglycemia level 1 | Change in percent Time hyperglycemia Level 1(180-250mg/dl) as assessed by CGM | 12 months |
| Assessment of hyperglycemia level 2 | Change in percent Time in hyperglycemia Level 2 ( >250mg/dl) as assessed by CGM | 12 months |
| Assessment of hypoglycemia | Change in percent Time in hypoglycemia Level 1 (54-70mg/dl) as assessed by CGM | 12 months |
| Assessment of percent time glucose in range | Change in percent Time in Range (70- 180 mg/dl) as assessed by CGM | 12 months |
| Fructosamine indices | Assessment of fructosamine | 12 months |
| Weekly fasting glucose indices | Assessment of change of weekly fasting glucose | 12 months |
| Insulin requirement indices | Assessment of the change in insulin requirement | 12 months |
| body weight assessment following dapagliflozin | Change in body weight at 6 months between dapagliflozin and placebo groups. | 6 months |
| body weight assessment following semaglutide | Change in body weight at 6 months following starting semaglutide compared to standard of care (SOC) group. | 6 months |
| body weight assessment following triple therapy | Change in body weight as assessed at 12 months on dapagliflozin and semaglutide compared to SOC therapy. | 12 months |
| Systolic Blood pressure assessment after triple therapy | Anti-hypertensive effects including change in systolic BP on dapagliflozin and semaglutide compared to SOC therapy. | 12 months |
| Diastolic Blood pressure assessment | Anti-hypertensive effects including change in diastolic BP on dapagliflozin and semaglutide compared to SOC therapy. | 12 months |
| Blood pressure medication use | Anti-hypertensive effects including change in numbers of BP medications required in patients dapagliflozin and semaglutide compared to SOC therapy. | 12 months |
| Level 2 hypoglycemia assessment | Differences in rates of hypoglycemic events Level 2 (<54mg/dl) between triple therapy and in standard therapy arm. | 12 months |
| Severe (level 3) hypoglycemia assessment | Differences in rates of hypoglycemic events Level 3 (<54mg/dl) characterized by altered mental and/or physical status requiring assistance) between triple therapy and in standard therapy arm. | 12 months |
| Level 1 hyperglycemia assessment | Differences in rates of Level 1 hyperglycemia (glucose levels >180mg/dl and <250mg dl) between triple therapy and in standard therapy arm. | 12 months |
| Level 2 hyperglycemia assessment | Differences in rates of Level 2 hyperglycemia (glucose levels <250mg dl) between triple therapy and in standard therapy arm. | 12 months |
| serum ketones assessment | Differences in rates of diabetic ketoacidosis defined as elevated serum ketones (greater than the upper limit of the normal range) in investigative arms. | 12 months |
| Urinary ketones assessment | Differences in rates of diabetic ketoacidosis defined as elevated urine ketones (greater than the upper limit of the normal range) in investigative arms. | 12 months |
| Diabetic ketoacidosis assessment | Differences in rates of diabetic ketoacidosis defined as Blood pH <7.3 in investigative arms. | 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |