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Completed

NCT Number: NCT02475070

Vildagliptin Versus Dapagliflozin on Glucagon

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lund University

Lund, 22184, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

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

Other names: Galvus

Dapagliflozin

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

Other names: Forxiga

Primary outcomes

  1. Glucagon Response to Meal

    Time frame: 240 min

    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. Incretin Hormones

    Time frame: 240min

    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)

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2015
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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