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Impact on Glycemic Variability After Treatment With Dapagliflozin on Type 2 Diabetes Patients

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Continuous glucose monitoring
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring dapagliflozin, glycemic variability

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects > 18-77 years-old
  • Both Male and female
  • Hba1c ≥ 7.5 % and ≤9%
  • BMI > 25 and <45 kg/m2
  • Type 2 diabetes diagnosis, drug-naïve

Exclusion Criteria:

  • Hba1c > 9%
  • Creatinine clearance CKD-EPI: < 60 mL/min
  • LADA or Type 1 diabetes
  • Gestational diabetes
  • Clinically significant disease like: hepatic, hematological, oncological, psychiatric or rheumatic disease.
  • Symptoms of marked uncontrolled diabetes: (marked poliuria or polidipsia + 10% weight loss prior the last 3 months enrollement)
  • Known hypersensitivity to dapagliflozin or any of the excipients of the product
  • eGFR persistently <45 mL/min/1.73 m2
  • Unstable or rapidly progressing renal disease
  • Patients with severe hepatic impairment (Child-Pugh class C)
  • Any major CV event/Vascular Disease within 3 months prior to signing the consent at enrolment, as assessed by the investigator
  • For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Daily dosage of dapagliflozin and metformin

Daily dosage of metformin

Arm Description

Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks

Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 2000 mg metformin for 12 weeks

Outcomes

Primary Outcome Measures

Impact of dapagliflozin in glycemic variability
Patients from both groups (dapagliflozin + metformin and metformin) will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA). Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit) comparing glycemic variability between them. Mean difference of glycaemic variability (MAGE) calculated in mmol/L.

Secondary Outcome Measures

Impact of dapagliflozin in insulin level concentration
Mean difference of insulin serum concentrations represented in μU/mL
Impact of dapagliflozin in Hba1c
Mean difference of HbA1c represented in %
Impact of dapagliflozin on patients weight
Mean difference of weight represented in kilograms
Impact of dapagliflozin in blood pressure
Mean difference of systolic and diastolic blood pressure represented in mmHg
Impact of dapagliflozin in waist circumference
Mean difference waist measured in centimeters

Full Information

First Posted
September 11, 2019
Last Updated
March 16, 2021
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
AztraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04090580
Brief Title
Impact on Glycemic Variability After Treatment With Dapagliflozin on Type 2 Diabetes Patients
Official Title
Impact on Glycaemic Variability, Oxidative Stress and Inflammatory Disease Biomarkers After Treatment With Dapagliflozin as Dual Therapy With Metformin on Mexican Type 2 Diabetes Patients. A Randomized, Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
AztraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Glycemic variability is refered as swings in glucemic concentration throughout the day, including preprandial and postprandial glucose, and it has been proposed that could be determinant in the development in microvascular complications of type 2 diabetes (Brownlee and Hirsch 2006) SGLT2 inhibitors (SGLT2i) are a novel group of medications for treating type 2 diabetes patients but their effect on glucose variability, and oxidative stress has not been determined as a primary endpoint in clinical trials of type 2 diabetes mellitus patients. The aim of this study is to compare the effect of SGLT2 inhibition on glucose variability, oxidative stress and inflammatory disease biomarkers (VCAM-1) on new onset type 2 DM patients.
Detailed Description
The aim of this study is to compare the effect of SGLT2 inhibition on glucose variability, oxidative stress and inflammatory disease biomarkers (VCAM-1) on new onset type 2 DM patients. Methods: The investigators will include 36 patients with type 2 diabetes diagnosis with an Hba1c ≥ 7.5% and ≤ 9%, with BMI > 25 and <45 kg/m2, drug-naïve subjects. Subjects enrolled will be randomized 1:1 to either receive a daily dosage of dapagliflozin 10 mg and 2000 mg metformin for 12 weeks (n=18) or 2000 mg metformin (n=18). Patients who do not tolerate metformin at 2000mg dose will be downtitrated to 1500 mg daily. In case patients do not tolerate 1500 mg daily, they will be excluded. Patients who do not achieve glycaemic control, another antihyperglycaemic drug can be used. Both groups will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA), or other available in Mexico. Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit). The main variables of interest are going to be in order of importance the delta of change (before and after study entry) of: 1.- glycaemic variability, 2.- change in Hba1c. 3.- change in oxidative stress status, 4. change in VCAM-1, 5.- change in weight, 6.- Blood pressure and 7.- waist circumference; before and after SGLT2i. The expected results are: compared to standard treatment, dapagliflozin arm will have lower glycaemic variability, higher reduction in Hba1c, lower oxidative stress, lower inflammsatory biomarker levels, and lower blood pressure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
dapagliflozin, glycemic variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
dapagliflozin vs standard care
Masking
None (Open Label)
Masking Description
open
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daily dosage of dapagliflozin and metformin
Arm Type
Experimental
Arm Description
Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks
Arm Title
Daily dosage of metformin
Arm Type
Experimental
Arm Description
Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 2000 mg metformin for 12 weeks
Intervention Type
Diagnostic Test
Intervention Name(s)
Continuous glucose monitoring
Intervention Description
Subjects enrolled will be randomized 1:1 to either receive a daily dosage of dapagliflozin 10 mg and 2000 mg metformin for 12 weeks (n=18) or 2000 mg metformin (n=18). Patients who do not tolerate metformin at 2000mg dose will be downtitrated to 1500 mg daily. In case patients do not tolerate 1500 mg daily, they will be excluded. Both groups will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA). Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit).
Primary Outcome Measure Information:
Title
Impact of dapagliflozin in glycemic variability
Description
Patients from both groups (dapagliflozin + metformin and metformin) will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA). Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit) comparing glycemic variability between them. Mean difference of glycaemic variability (MAGE) calculated in mmol/L.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Impact of dapagliflozin in insulin level concentration
Description
Mean difference of insulin serum concentrations represented in μU/mL
Time Frame
12 weeks
Title
Impact of dapagliflozin in Hba1c
Description
Mean difference of HbA1c represented in %
Time Frame
12 weeks
Title
Impact of dapagliflozin on patients weight
Description
Mean difference of weight represented in kilograms
Time Frame
12 weeks
Title
Impact of dapagliflozin in blood pressure
Description
Mean difference of systolic and diastolic blood pressure represented in mmHg
Time Frame
12 weeks
Title
Impact of dapagliflozin in waist circumference
Description
Mean difference waist measured in centimeters
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects > 18-77 years-old Both Male and female Hba1c ≥ 7.5 % and ≤9% BMI > 25 and <45 kg/m2 Type 2 diabetes diagnosis, drug-naïve Exclusion Criteria: Hba1c > 9% Creatinine clearance CKD-EPI: < 60 mL/min LADA or Type 1 diabetes Gestational diabetes Clinically significant disease like: hepatic, hematological, oncological, psychiatric or rheumatic disease. Symptoms of marked uncontrolled diabetes: (marked poliuria or polidipsia + 10% weight loss prior the last 3 months enrollement) Known hypersensitivity to dapagliflozin or any of the excipients of the product eGFR persistently <45 mL/min/1.73 m2 Unstable or rapidly progressing renal disease Patients with severe hepatic impairment (Child-Pugh class C) Any major CV event/Vascular Disease within 3 months prior to signing the consent at enrolment, as assessed by the investigator For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Angel Gomez Samano, MD
Phone
55 54870900
Ext
2405
Email
gsamano83@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Angel Gomez Samano, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''
City
Ciudad de mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Gómez Sámano, MD
Phone
55 54870900
Ext
2405
Email
miguelangelgomezsamano@gmail.com
First Name & Middle Initial & Last Name & Degree
Miguel Angel Gómez Sámano, MD
First Name & Middle Initial & Last Name & Degree
Daniel Cuévas Ramos, MD
First Name & Middle Initial & Last Name & Degree
Francisco Javier Gómez Pérez, MD
First Name & Middle Initial & Last Name & Degree
Horacio Correa Carranza, MD
First Name & Middle Initial & Last Name & Degree
Alejandra Domínguez Sánchez, MD

12. IPD Sharing Statement

Learn more about this trial

Impact on Glycemic Variability After Treatment With Dapagliflozin on Type 2 Diabetes Patients

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