Vildagliptin Versus Dapagliflozin on Glucagon

NCT ID: NCT02475070

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vildagliptin first

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

Group Type: ACTIVE_COMPARATOR

Vildagliptin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Dapagliflozin first

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

Group Type: ACTIVE_COMPARATOR

Vildagliptin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Galvus; Forxiga

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Bo Ahren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Ahren, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Lund University

Lund, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

350A

Identifier Type: -

Identifier Source: org_study_id