| Trial ID: | L7011 |
| Source ID: | NCT02518945
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02518945/results
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Insulin|DRUG: Liraglutide|DRUG: Dapagliflozin placebo
|
| Outcome Measures: |
Primary: Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo., T1D. Conservatively estimating a difference in mean HbA1c (the primary end point) of 0.5% before and after the treatment, and a sample size of 30 (2:1 drug to placebo ratio) should provide adequate power (.8) to detect a significant difference (.05) provided the standard deviation of the residuals in not greater than 0.4%. The sample size includes an additional 20% to account for the potential dropout. Changes in these end points were calculated by averaging the differences in weekly average values from baseline., 12 weeks | Secondary: Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dl, Comparison of the change in time spent at normal glucose concentrations between 70-180mg/dl after treatment with 12 weeks of dapagliflozin in addition to liraglutide and insulin., 12 weeks|Change in 24-hour Urine Glucose Excretion., Comparison of change in 24-hour urine glucose excretion after 12 weeks of treatment of dapagliflozin in addition to liraglutide and insulin compared to baseline., 12 weeks.|Change in Total Daily Insulin Requirements, Comparison of the change from baseline in total daily insulin requirements in units per kilogram after treatment 12 weeks of dapagliflozin or placebo in addition to liraglutide and insulin., 12 weeks|Change in Body Weight, Comparison of change from baseline in Body weight after 12 weeks treatment with dapagliflozin or placebo in addition to liraglutide and insulin., 12 weeks|Change in Systolic Blood Pressure Before and After Treatment, Comparison of Systolic blood pressure in mm Hg before and after 12 weeks treatment with dapagliflozin in addition to liraglutide and insulin., 12 weeks|Change in Blood Ketone Bodies, change from baseline in blood ketone bodies (measured as beta-hydroxybutyrates) after 12 weeks treatment with dapagliflozin or placebo in addition to liraglutide and insulin., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University at Buffalo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
26
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-08
|
| Completion Date: |
2016-04
|
| Results First Posted: |
2024-01-24
|
| Last Update Posted: |
2024-01-24
|
| Locations: |
ECMC Ambulatory Center, 3rd Floor, Buffalo, New York, 14215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02518945
|
