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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.
This is a Phase IV, single site, randomized, open-label, 3 treatment group, parallel study comparing BYDUREON-BCiseTM plus FARXIGATM to BYDUREON-BCiseTM alone and FARXIGATM alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week Lead-in Period, during which patients will be given a blood glucose meter and fitted with a blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment.
After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1 ratio to one of three open-label treatment arms to achieve approximately 20 subjects per treatment arm.
The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week open-label Treatment Period and a 10-week Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide 2 mg plus Dapagaliflozin 10 mg | Experimental | Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment |
|
| Exenatide 2 mg | Active Comparator | Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment |
|
| Dapagaliflozin 10 mg | Active Comparator | Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide 2 MG | Drug | Glucagon-like peptide-1 receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| MAGE | Compare the change in mean amplitude of glucose excursions from baseline to week 14 | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose | Change in fasting plasma glucose from baseline to week 14 | 14 weeks |
| HbA1c | Change in HbA1c from baseline to week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Dapagliflozin 10 MG | Drug | sodium-glucose co-transporter 2 (SGLT2) inhibitor |
|
|
| 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 |
| D004700 | Endocrine System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |