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| ID | Type | Description | Link |
|---|---|---|---|
| 1K12DK094714-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will be an open-label, cross-over study as subjects will be studied under both study conditions - suspension of subcutaneous insulin infusion via pump during treatment with insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with insulin and canagliflozin.
The study will consist of 4 visits: an enrollment/screening visit, a control visit with pump suspension prior to treatment with canagliflozin, a visit with pump suspension while on canagliflozin and an end of study visit. Each of the pump suspension visits will be approximately 20-hour overnight admissions to the Hospital Research Unit (HRU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal interruption | Active Comparator | Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit |
|
| Basal interruption with canagliflozin | Experimental | Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canagliflozin | Drug | basal interruption with canagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin | The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor. | 20 hours |
| Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal | 20 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion | 20 hours | |
| Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion | 20 hours |
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Inclusion Criteria:
Exclusion Criteria:
Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
Renal impairment, determined as eGFR < 60 ml/minute/1.73m2
Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
Use of metformin, thiazolidinedione or GLP1 agonist within 1 month prior to screening visit. For those subjects on canagliflozin or other SGLT2 inhibitors, an alternate study procedure may be utilized as described above
Use of any medications (besides insulin or SGLT2 inhibitor) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed as long as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites
History of hypoglycemic seizure within last 3 months
History of diabetic ketoacidosis (DKA) requiring medical intervention (ie. emergency room visit and/or hospitalization) within 1 month prior to the screening visit
Allergies or contraindication to the contents of canagliflozin tablets or insulin
Volume depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics who cannot carefully monitor their volume status should be excluded from the study
Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Recurrent GU (genitourinary) infections
Uncircumcised males secondary to increased risk of development of GU infections
History of hypotension, defined as blood pressure (BP) <10th% for age and sex
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| Name | Affiliation | Role |
|---|---|---|
| Neha Patel, DO | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Basal Interruption With or Without Canagliflozin | Subjects will undergo basal interruption with or without canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Basal Interruption With or Without Canagliflozin | Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin | The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor. | Posted | Mean | Standard Error | mg/dL | 20 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Basal Interruption | Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit basal interruption without canagliflozin: basal interruption |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Candidiasis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neha S. Patel, DO | Yale Pediatric Diabetes | 203-764-6747 | neha.patel@yale.edu |
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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 |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| basal interruption without canagliflozin | Other | basal interruption |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin |
|
|
| Primary | Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal | Posted | Mean | Standard Error | mmol/L | 20 hours |
|
|
|
| Secondary | Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion | Posted | Mean | Standard Error | mmol/L | 20 hours |
|
|
|
| Secondary | Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion | Posted | Mean | Standard Error | pg/mL | 20 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Basal Interruption With Canagliflozin | Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit canagliflozin: basal interruption with canagliflozin | 0 | 10 | 0 | 10 | 1 | 10 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |