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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Vildagliptin Versus Dapagliflozin on Glucagon

NCTNCT02475070 (opens ClinicalTrials.gov in a new tab)Other id350A
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 4
Enrollment
28 participants (actual)
Sponsor
Lund University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Sweden

Start
Jan 2016
Primary completion
Jun 2017
Completion
Jun 2017
First posted
18 Jun 2015 (estimated)
Last update posted
2 May 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

    Vildagliptin Versus Dapagliflozin on Glucagon

    NCT02475070

    Jan 2016 to Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • VildagliptinDrug
  • DapagliflozinDrug

Arms2

  • Active comparator

    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

  • Active comparator

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glucagon Response to Meal

    Time frame · 240 min

    Registry 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)

Secondary outcomes(1)

  1. Incretin Hormones

    Time frame · 240min

    Registry 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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 240 min

Glucagon Response to Meal

GroupValue (nmol/l min)Spread
Vildagliptin Treatment39.02.6
Dapagliflozin Treatment38.82.7
Secondary and other outcome results(1)
Secondary outcomeMean· 240min

Incretin Hormones

GroupValue (nmol/l min)Spread
Vildagliptin Treatment3.80.5
Dapagliflozin Treatment3.70.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
VildagliptinTreatment with vildagliptin 50mg twice daily for two weeks0 / 280 / 284 / 28
DapagliflozinTreatment with dapagliflozin 10 mg once daily for two weeks0 / 280 / 285 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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