Clinical trial NCT02475070: Vildagliptin Versus Dapagliflozin on Glucagon
Official title: Study of the Effect of Vildagliptin Versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Glucagon Response to Meal
timeFrame: 240 min
Secondary outcomes:
measure: Incretin Hormones
timeFrame: 240min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Bo Ahren, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: