Vildagliptin Versus Dapagliflozin on Glucagon

Launched by LUND UNIVERSITY · Jun 17, 2015

Keywords

ClinConnect Summary

The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis. Subjects will therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks followed by a meal test in which glucagon levels will be determined.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written consent has been given.
• • 2. Patients with type 2 diabetes treated with a stable dose of metformin during the last three months
• • 3. Age 20-70 years.
• • 4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
• • 5. Ability to complete the study
• Exclusion Criteria:
• • 1. Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
• • 2. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
• • 3. Type 1 diabetes, positive GAD antibodies
• • 4. Estimated glomerular filtration rate \<60 ml/min
• • 5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
• • 6. Any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes.
• • 7. Any history of acute pancreatitis
• • 8. Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
• • 9. Liver disease such as cirrhosis or chronic active hepatitis
• • 10. History of coronary heart disease or heart failure class III or IV
• • 11. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
• • 12. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
• • 13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
• • 14. Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core