| Trial ID: | L2633 |
| Source ID: | NCT02962492
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| Associated Drug: |
Exenatide/Exenatide Extended Release
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| Title: |
An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02962492/results
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| Conditions: |
Evaluate Ketogenic Stress
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| Interventions: |
DRUG: Exenatide/Exenatide extended release|DRUG: Dapagliflozin|DRUG: Placebo
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| Outcome Measures: |
Primary: Change in Beta-hydroxybutyrate Levels in Blood, Beta-hydroxybutyrate (BHB) was measured in blood during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0., 12 weeks | Secondary: Change in HbA1c Following Treatment, Hemoglobin A1c (HbA1c) was measured in basal conditions in all the groups at week 0 and week 12 of treatment. The change in HbA1c from baseline at 12 weeks is calculated as: HbA1c at week 12 - HbA1c at week 0., 12 weeks|Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment, Beta-hydroxybutyrate (BHB) was measured in urine during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0., 12 weeks|Change in Plasma Glucagon, change in basal plasma glucagon after 12 weeks of dapagliflozin and Bydureon or combination of both treatments compared to baseline, 12 weeks|Change in Total Insulin Dose, change in total (basal or long acting and short acting) insulin daily dose calculated as daily units/Kg body weight at 12 weeks from baseline (0 week). Long acting or basal insulin dose (in units of insulin) plus short acting (meal) insulin doses administered through the day and reported by patients in patients logs or from insulin pumps are added and divided by body weight in Kg. The reported total insulin dose/Kg represents the average of last 3-7 days before the visit., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University at Buffalo | Collaborators: AstraZeneca
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
70
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2016-11-01
|
| Completion Date: |
2021-10-24
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| Results First Posted: |
2024-02-29
|
| Last Update Posted: |
2024-02-29
|
| Locations: |
Diabetes and Endocrinology Research Center of WNY, Williamsville, New York, 14221, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02962492
|
