NCT02475070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 2, 2019

Completed
Last Updated

May 2, 2019

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

June 15, 2015

Results QC Date

November 9, 2017

Last Update Submit

January 31, 2019

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incretin Hormones

    240min

Study Arms (2)

Vildagliptin first

ACTIVE COMPARATOR

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

Drug: VildagliptinDrug: Dapagliflozin

Dapagliflozin first

ACTIVE COMPARATOR

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

Drug: VildagliptinDrug: Dapagliflozin

Interventions

VildagliptinDRUG

Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks

Also known as: Galvus
Dapagliflozin firstVildagliptin first
DapagliflozinDRUG

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

Also known as: Forxiga
Dapagliflozin firstVildagliptin first

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, 22184, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptindapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr Bo Ahrén
Organization
Lund University
Bo.Ahren@med.lu.se
+46462220758

Study Officials

  • Bo Ahren, MD PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 18, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 2, 2019

Results First Posted

May 2, 2019

Record last verified: 2018-08

Locations

SE(1)