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Vildagliptin Versus Dapagliflozin on Glucagon

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Vildagliptin

Dapagliflozin

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written consent has been given.
Patients with type 2 diabetes treated with a stable dose of metformin during the last three months
Age 20-70 years.
HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
Ability to complete the study

Exclusion Criteria:

Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
Type 1 diabetes, positive GAD antibodies
Estimated glomerular filtration rate <60 ml/min
Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
Any history of acute pancreatitis
Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Liver disease such as cirrhosis or chronic active hepatitis
History of coronary heart disease or heart failure class III or IV
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.
Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core

Sites / Locations

Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Vildagliptin first

Dapagliflozin first

Arm 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 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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02475070

First Posted

June 15, 2015

Last Updated

January 31, 2019

Sponsor

Lund University

1. Study Identification

Unique Protocol Identification Number

NCT02475070

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lund University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin first

Arm Type

Active Comparator

Arm 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

Arm Title

Dapagliflozin first

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Other Intervention Name(s)

Galvus

Intervention Description

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

Intervention Name(s)

Dapagliflozin

Other Intervention Name(s)

Forxiga

Intervention Description

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

Primary Outcome Measure Information:

Title

Glucagon Response to Meal

Description

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)

Time Frame

240 min

Secondary Outcome Measure Information:

Title

Incretin Hormones

Description

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)

Time Frame

240min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written consent has been given. Patients with type 2 diabetes treated with a stable dose of metformin during the last three months Age 20-70 years. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1. Ability to complete the study Exclusion Criteria: Use of other glucose-lowering therapy than metformin within three months prior to visit 1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly. Type 1 diabetes, positive GAD antibodies Estimated glomerular filtration rate <60 ml/min Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes. Any history of acute pancreatitis Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Liver disease such as cirrhosis or chronic active hepatitis History of coronary heart disease or heart failure class III or IV 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. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Ahren, MD PhD

Organizational Affiliation

Lund University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lund University

City

Lund

ZIP/Postal Code

22184

Country

Sweden

12. IPD Sharing Statement

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Vildagliptin Versus Dapagliflozin on Glucagon

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