Vildagliptin Versus Dapagliflozin on Glucagon

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University
• Treatments: Dapagliflozin; Glucagon; Vildagliptin

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