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Effect of Anti-diabetic Drugs on Glycemic Variability

NCT02925559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-03-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin

The active treatment will include a 10 mg dose of dapagliflozin orally once a day.

DRUG

Gliclazide MR

As comparator, gliclazide MR will be administered at a dose of 120 mg orally once a day.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Centro de Diabetes Curitiba Ltda

    lead OTHER

Principal Investigators

  • Andre GD Vianna, MD · Centro de Diabetes Curitiba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-02-28
Completion
2019-01-31

Countries

  • Brazil

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02925559 on ClinicalTrials.gov