| Trial ID: | L2691 |
| Source ID: | NCT03970044
|
| Associated Drug: |
Exenatide 2 Mg
|
| Title: |
Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Exenatide 2 MG|DRUG: Dapagliflozin 10 MG
|
| Outcome Measures: |
Primary: MAGE, Compare the change in mean amplitude of glucose excursions from baseline to week 14, 14 weeks | Secondary: Fasting Plasma Glucose, Change in fasting plasma glucose from baseline to week 14, 14 weeks|HbA1c, Change in HbA1c from baseline to week 14, 14 weeks|Weight, Change in weight from baseline to week 14, 14 weeks|Blood Pressure, Change in blood pressure from baseline to week 14, 14 weeks|Blood Glucose Variability, Variability in blood glucose from baseline to weeks 4, 10 and 14, 14 weeks|24 Hour Mean Blood Glucose, Change in 24 mean blood glucose at multiple time points, 17 weeks|Blood Glucose Time In Range, Measure the proportion of time patients who had plasma glucose measurements of: \<70 mg/dL, \>70 mg/dL and \<180 mg/dL or \>180 mg/dL, 14 weeks
|
| Sponsor/Collaborators: |
Sponsor: Consano Clinical Research, LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
67
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-07-02
|
| Completion Date: |
2021-06-01
|
| Results First Posted: |
|
| Last Update Posted: |
2021-08-30
|
| Locations: |
Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03970044
|
