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Effect of Anti-diabetic Drugs on Glycemic Variability (EFFORT)

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ClinicalTrials.gov Identifier: NCT02925559
Recruitment Status : Unknown
Verified October 2016 by Centro de Diabetes Curitiba Ltda.
Recruitment status was:  Not yet recruiting
First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Centro de Diabetes Curitiba Ltda

Brief Summary:

Objectives

Primary objective:

To access the change from baseline to week 12 in MAGE index of glycemic variability measured by CGMS for dapagliflozin versus. gliclazide MR.

Secondary objectives:

  1. Change from baseline to week 12 in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, postprandial glucose and achievement of HbA1c ≤6.5% and <7% at the end of the study) for dapagliflozin versus gliclazide MR.
  2. Change from baseline to week 12 in glycemic variability defined by the interquartile range (IQR - interval between 25th and 75th percentiles) measured by CGMS for dapagliflozin versus gliclazide MR.
  3. Change from baseline to week 12 in glycemic variability measured by the Standard Deviation of the mean glycemia (SD) measured by CGMS for dapagliflozin versus gliclazide MR.
  4. Change from baseline to week 12 in glycemic variability measured by the Coefficient of Variation (CV) measured by CGMS for dapagliflozin versus gliclazide MR.
  5. Change from baseline to week 12 in the time spent on hypoglycemic range (glycemia <70mg/dL) measured by CGMS for dapagliflozin versus gliclazide MR.

Study design This is a single-center, prospective, randomized, open-label, comparative, phase IV study to compare the effects of gliclazide MR and dapagliflozin on Glycemic Variability in patients with Type 2 Diabetes Mellitus (T2DM). All patients should be treatment naïve or receive standard of care therapy for T2DM as well as for co-morbidities based on accepted guidelines and local best practices.

Target patient population Approximately 120 patients with T2DM will be randomized from study site. Patients who were treated with metformin only and had inadequate glycemic control at the time of enrollment as well as treatment naïve or non-medically treated (e.g., diet) patients, will be enrolled and receive either dapagliflozin 10mg qd or comparator gliclazide MR 120mg qd in addition to standard of care treatment for T2DM and co-morbidities.

Investigational product, dosage and mode of administration Dapagliflozin 10mg tablets administered orally once daily for 12 weeks.

Comparator, dosage and mode of administration Gliclazide MR 60mg tablets administered orally, 2 tablets once daily for 12 weeks.

Duration of treatment The treatment with study medication or comparator will have a total duration of 15 weeks.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Drug: Gliclazide MR Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes
Study Start Date : October 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin
The active treatment will include a 10 mg dose of dapagliflozin orally once a day.
Drug: Dapagliflozin
The active treatment will include a 10 mg dose of dapagliflozin orally once a day.
Other Names:
  • Farxiga
  • Forxiga

Active Comparator: Gliclazide MR
As comparator, gliclazide MR will be administered at a dose of 120 mg orally once a day.
Drug: Gliclazide MR
As comparator, gliclazide MR will be administered at a dose of 120 mg orally once a day.
Other Name: Diamicron MR




Primary Outcome Measures :
  1. Glycemic Variability [ Time Frame: 12 weeks ]
    Glycemic Variability defined by the mean amplitude of glycemic excursion (MAGE) measured by CGMS


Secondary Outcome Measures :
  1. Glycated hemoglobin A1c (HbA1c) measured as percentage (%) [ Time Frame: 12 weeks ]
    Glycated hemoglobin A1c (HbA1c) measured by HPLC (High Performance Liquid Chromatography)

  2. Fasting plasma glucose (FPG) measured by hexokinase method (mg/dL) [ Time Frame: 12 weeks ]
    Fasting plasma glucose (FPG) measured by hexokinase method after at least 8 hours in fasting state.

  3. Postprandial glucose (PPG) measured by hexokinase method (mg/dL) [ Time Frame: 12 weeks ]
    Postprandial glucose (PPG) measured by hexokinase method 2 hours after lunch

  4. HbA1c ≤6.5% and <7% [ Time Frame: 12 weeks ]
    Achievement of HbA1c ≤6.5% and <7% at the end of the study

  5. Glycemic variability 2 [ Time Frame: 12 weeks ]
    Glycemic variability defined by the interquartile range (IQR - interval between 25th and 75th percentiles) measured by CGMS

  6. Glycemic variability 3 [ Time Frame: 12 weeks ]
    Glycemic Variability defined by the Standard Deviation of the mean glycaemia (SD) measured by CGMS

  7. Glycemic variability 4 [ Time Frame: 12 weeks ]
    Glycemic Variability defined by the Coefficient of Variation (CV) measured by CGMS

  8. Hypoglycemia [ Time Frame: 12 weeks ]
    Time spent on hypoglycemic range (glycaemia <70mg/dL) measured by CGMS



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A. Informed consent form obtained before any study-related activity. Study-related activities are any procedure that would not be performed during the normal treatment of the patient.

B. All study subjects must be patients diagnosed with type 2 diabetes based on current guidelines of Brazilian Society of Diabetes and/or American Diabetes Association (ADA) and they should have all the following criteria:

  • Age ≥40 years old.
  • HbA1c ≥7% at randomization.
  • Drug naïve or metformin treated with a stable dose for at least 3 months.

Exclusion Criteria:

  1. Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of randomization.
  2. Patient on chronic dialysis and/or renal transplantation and/or serum creatinine >1.5 mg/dL and/or estimated glomerular filtration rate (eGFR) < 45ml/min (MDRD) and/or Creatinine Clearance <60ml/min.
  3. Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (>30 consecutive days).
  4. Current or previous treatment with any SGLT-2 inhibitor within 2 months prior to randomization.
  5. Current or previous treatment with any type of insulin within 2 months prior to randomization.
  6. Current or previous treatment with any sulphonylurea and meglitinide within 2 months prior to randomization.
  7. Current or previous treatment with any DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist within 2 months prior to randomization.
  8. Current or previous treatment with acarbose within 2 months prior to randomization.
  9. Sustained arterial hypertension ≥160/100mm Hg.
  10. Body mass index (BMI) >50 kg/m².
  11. HbA1c ≥10.5% at randomization.
  12. Transaminases (aspartate aminotransferase and/or alanine aminotransferase) >2.5 x upper limit of normal.
  13. Total bilirubin >2.5 x upper limit of normal
  14. Chronic liver disease or alcoholic liver disease.
  15. LDL-cholesterol >250 mg/dL (>6.48 mmol/L).
  16. Triglycerides >1000 mg/dL (>11.3 mmol/L).
  17. HDL-cholesterol <25 mg/dL (<0.64 mmol/L).
  18. Positive haematuria observed in urine sample obtained in the run-in visit.
  19. Prescription of any investigational medication within 3 months before the screening visit.
  20. Prescription of any investigational medication within the period between 3 months and one year before the screening visit (visit 1), unless there is a direct benefit to the study subject, at the discretion of the investigator.
  21. Pregnant or breastfeeding patients.
  22. Previous participation on this study.
  23. Individuals at risk for poor adherence to the protocol or medication.
  24. Any condition that makes the patient unable to complete the study within 3 months.

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): NCT02925559


Contacts
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Contact: Andre GD Vianna, MD +554130231252 drandrevianna@gmail.com
Contact: Marinez PP Jucovski +554130231252 pesquisaclinica_mari@yahoo.com.br

Locations
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Brazil
Centro de Diabetes Curitiba
Curitiba, Parana, Brazil, 80810040
Sponsors and Collaborators
Centro de Diabetes Curitiba Ltda
AstraZeneca
Investigators
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Principal Investigator: Andre GD Vianna, MD Centro de Diabetes Curitiba

Publications:

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Responsible Party: Centro de Diabetes Curitiba Ltda
ClinicalTrials.gov Identifier: NCT02925559     History of Changes
Other Study ID Numbers: ESR-14-10377
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Centro de Diabetes Curitiba Ltda:
Diabetes Mellitus, Type 2
Glycemic Variability
Dapagliflozin
Gliclazide MR
Continuous Glucose Monitoring
Mean Amplitude of Glycemic Excursions
MAGE
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Gliclazide
Hypoglycemic Agents
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs