Effect of Anti-diabetic Drugs on Glycemic Variability

NCT02925559 | Completed Phase 4

• 1 other identifier: ESR-14-10377
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Glycemic Variability; Dapagliflozin; Gliclazide MR; Continuous Glucose Monitoring; Mean Amplitude of Glycemic Excursions; MAGE

Outcome Measures

Primary Outcomes (1)

• Glycemic Variability

  Glycemic Variability defined by the mean amplitude of glycemic excursion (MAGE) measured by CGMS

  12 weeks

Secondary Outcomes (8)

• Glycated hemoglobin A1c (HbA1c) measured as percentage (%)

  12 weeks

• Fasting plasma glucose (FPG) measured by hexokinase method (mg/dL)

  12 weeks

• Postprandial glucose (PPG) measured by hexokinase method (mg/dL)

  12 weeks

• HbA1c ≤6.5% and <7%

  12 weeks

• Glycemic variability 2

  12 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin

Gliclazide MR

ACTIVE COMPARATOR

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

Drug: Gliclazide MR

Interventions

Dapagliflozin DRUG

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

Also known as: Farxiga, Forxiga

Dapagliflozin

Gliclazide MR DRUG

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

Also known as: Diamicron MR

Gliclazide MR

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of randomization.
• 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.
• Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (\>30 consecutive days).
• Current or previous treatment with any SGLT-2 inhibitor within 2 months prior to randomization.
• Current or previous treatment with any type of insulin within 2 months prior to randomization.
• Current or previous treatment with any sulphonylurea and meglitinide within 2 months prior to randomization.
• Current or previous treatment with any DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist within 2 months prior to randomization.
• Current or previous treatment with acarbose within 2 months prior to randomization.
• Sustained arterial hypertension ≥160/100mm Hg.
• Body mass index (BMI) \>50 kg/m².
• HbA1c ≥10.5% at randomization.
• Transaminases (aspartate aminotransferase and/or alanine aminotransferase) \>2.5 x upper limit of normal.
• Total bilirubin \>2.5 x upper limit of normal
• Chronic liver disease or alcoholic liver disease.
• LDL-cholesterol \>250 mg/dL (\>6.48 mmol/L).

Sponsors & Collaborators

• Centro de Diabetes Curitiba Ltda: lead
• AstraZeneca: collaborator

Study Sites (1)

Centro de Diabetes Curitiba

Curitiba, Paraná, 80810040, Brazil

Location

Related Publications (29)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Gliclazide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Andre GD Vianna, MD

  Centro de Diabetes Curitiba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)