Trial · Interventional
CompletedPhase 4Registry dataEffectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 67 participants (actual)
- Sponsor
- Consano Clinical Research, LLC · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 2 Jul 2019
- Primary completion
- 1 Jun 2021
- Completion
- 1 Jun 2021
- First posted
- 31 May 2019
- Last update posted
- 30 Aug 2021
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.
NCT039700442 Jul 2019 to 1 Jun 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Interventions
- Exenatide 2 MGDrug
- Dapagliflozin 10 MGDrug
Arms3
Experimental
Exenatide 2 mg plus Dapagaliflozin 10 mg
Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment
Active comparator
Exenatide 2 mg
Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment
Active comparator
Dapagaliflozin 10 mg
Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment
Primary outcomes1
Outcomes the sponsor listed as primary.
MAGE
Time frame · 14 weeks
Registry description
Compare the change in mean amplitude of glucose excursions from baseline to week 14
Secondary outcomes(7)
Fasting Plasma Glucose
Time frame · 14 weeks
Registry description
Change in fasting plasma glucose from baseline to week 14
HbA1c
Time frame · 14 weeks
Registry description
Change in HbA1c from baseline to week 14
Weight
Time frame · 14 weeks
Registry description
Change in weight from baseline to week 14
Blood Pressure
Time frame · 14 weeks
Registry description
Change in blood pressure from baseline to week 14
Blood Glucose Variability
Time frame · 14 weeks
Registry description
Variability in blood glucose from baseline to weeks 4, 10 and 14
24 Hour Mean Blood Glucose
Time frame · 17 weeks
Registry description
Change in 24 mean blood glucose at multiple time points
Blood Glucose Time In Range
Time frame · 14 weeks
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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