Vildagliptin Versus Dapagliflozin on Glucagon

Type 2 Diabetes Clinical Trial

Official title:

Study of the Effect of Vildagliptin Versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475070
• Other study ID #: 350A
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Vildagliptin
Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks
• Dapagliflozin
Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks

Locations

Country	Name	City	State
Sweden	Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon Response to Meal	Area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150,180 and 240 minutes post-dose)	240 min
Secondary	Incretin Hormones	Area under the curve (AUC) of the 180 min glucagon like peptide-1 levels after mixed meal (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 minutes post-dose)	240min