Vildagliptin Versus Dapagliflozin on Glucagon

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02475070
• Date of registration: 15/06/2015
• Prospective Registration: Yes
• Primary sponsor: Lund University
• Public title: Vildagliptin Versus Dapagliflozin on Glucagon
• Scientific title: Study of the Effect of Vildagliptin Versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects With Type 2 Diabetes
• Date of first enrolment: January 2016
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02475070
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Sweden

Contacts

• Name: Bo Ahren, MD PhD
• Affiliation: Lund University

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Vildagliptin

Drug: Dapagliflozin

Primary Outcome(s)

Glucagon Response to Meal [Time Frame: 240 min]

Secondary Outcome(s)

Incretin Hormones [Time Frame: 240min]

Secondary ID(s)

350A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02475070