| Trial ID: | L6880 |
| Source ID: | NCT02613897
|
| Associated Drug: |
Saxagliptin
|
| Title: |
ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02613897/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Saxagliptin|DRUG: Dapagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Endogenous Glucose Production (EGP), All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP., Baseline and 16 weeks | Secondary: Change in Body Weight, Change in body weight from baseline to 16 weeks, Baseline to 16 weeks|Change in BMI, Change in BMI (body mass index) from study start to 16 weeks, Change from baseline to 16 weeks|HBA1c, Change in blood glucose level measured over a 3 month period from study start to 16 weeks, Change from baseline to 16 weeks|Mean Oral Glucose Tolerance Test (OGTT), Measure of change in OGTT from study start to 16 weeks, Change from baseline to 16 weeks|Change in Lipid Oxidation, Change in lipid oxidation percentage from baseline to 16 weeks, Change from baseline to 16 weeks|Change in Glucose Oxidation, Change in percentage of glucose oxidation from study start to 16 weeks, Change from baseline to 16 weeks|Change in Fasting Plasma Glucagon (FPG), A measure of the change in fasting plasma glucagon from study start to 16 weeks, Change from baseline to 16 weeks|Change in Free Fatty Acids (FFA), Measure of change in Free Fatty Acids from study start to 16 weeks, Change from baseline to 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-01
|
| Completion Date: |
2018-06-30
|
| Results First Posted: |
2019-08-14
|
| Last Update Posted: |
2019-08-14
|
| Locations: |
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02613897
|
