Vildagliptin Versus Dapagliflozin on Glucagon

Lund University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02475070

350A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Vildagliptin first

Active Comparator group

Description:

Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks

Treatment:

Drug: Vildagliptin

Drug: Dapagliflozin

Dapagliflozin first

Active Comparator group

Description:

Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks

Treatment:

Drug: Vildagliptin

Drug: Dapagliflozin