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Trial record 27 of 748 for:    Area Under Curve AND meal

Vildagliptin Versus Dapagliflozin on Glucagon

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ClinicalTrials.gov Identifier: NCT02475070
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Vildagliptin Drug: Dapagliflozin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: 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
Other Name: Galvus

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
Other Name: Forxiga

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
Drug: 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
Other Name: Galvus

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
Other Name: Forxiga




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475070


Locations
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Sweden
Lund University
Lund, Sweden, 22184
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Bo Ahren, MD PhD Lund University
  Study Documents (Full-Text)

Documents provided by Bo Ahren, Lund University:
Study Protocol  [PDF] March 28, 2016
Statistical Analysis Plan  [PDF] March 28, 2016


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Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT02475070     History of Changes
Other Study ID Numbers: 350A
First Posted: June 18, 2015    Key Record Dates
Results First Posted: May 2, 2019
Last Update Posted: May 2, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Vildagliptin
Glucagon
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors