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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005549-30 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell glucagon release.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-D-DG | Experimental | The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose). |
|
| DS-DG-D | Experimental | The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose). |
|
| D-DG-DS | Experimental | The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose). |
|
| D-DS-DG | Experimental | The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose). |
|
| DG-D-DS | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma glucagon levels from baseline to 0.5 hour after single-dose administration of drug. | Washout period of 2-6 weeks between the interventions | At start and 0.5 hour after the start of each intervention |
| Change in plasma glucagon levels from baseline to 1 hour after single-dose administration of drug. | At start and 1 hour after the start of each intervention | |
| Change in plasma glucagon levels from baseline to 2 hours after single-dose administration of drug. | At start and 2 hours after the start of each intervention | |
| Change in plasma glucagon levels from baseline to 3 hours after single-dose administration of drug. | At start and 3 hours after the start of each intervention | |
| Change in plasma glucagon levels from baseline to 5 hours after single-dose administration of drug. | At start and 5 hours after the start of each intervention | |
| Change in plasma glucagon levels from baseline to 5.5 hours after single-dose administration of drug. | At start and 5.5 hours after the start of each intervention | |
| Change in plasma glucagon levels from baseline to 6 hours after single-dose administration of drug. | At start and 6 hours after the start of each intervention | |
| Change in plasma glucagon levels from baseline to 7 hours after single-dose administration of drug. | At start and 7 hours after the start of each intervention |
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Inclusion Criteria:
Males and females aged 18 - 75.
Female subjects must meet all of the following criteria:
i. Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
BMI 20 - 35.
Clinical T2D diagnosis at least 6 months prior to enrolment.
Metformin treatment, with stable dose for at least 1 month.
HbA1c 55 - 86 mmol/mol (7,2-10 % DCCT).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan W Eriksson, MD PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Medical Sciences Uppsala University Hospital | Uppsala | 75185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30137410 | Derived | Lundkvist P, Pereira MJ, Kamble PG, Katsogiannos P, Langkilde AM, Esterline R, Johnsson E, Eriksson JW. Glucagon Levels During Short-Term SGLT2 Inhibition Are Largely Regulated by Glucose Changes in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jan 1;104(1):193-201. doi: 10.1210/jc.2018-00969. |
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The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
|
| DG-DS-D | Experimental | The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose). |
|
| Saxagliptin |
| Drug |
|
| Glucose | Drug |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C502994 | saxagliptin |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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