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Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone

NCT04090580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-05-22

Study results available
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Summary

This study will compare the effect of Dapagliflozin added to Metformin vs Metformin alone on blood sugar fluctuations of adults with a recent diagnosis of Type 2 Diabetes (T2D). The duration of the protocol will be 12 weeks. Continuous glucose monitoring will be measured before and at the end of the intervention. The questions this protocol will answer include:

* Is there a difference in blood sugar fluctuations when Dapagliflozin is added to Metformin compared with Metformin alone in adults with type 2 Diabetes?
* Does Dapagliflozin added to Metformin improve blood glucose control in patients with type 2 Diabetes?

Conditions

Interventions

DIAGNOSTIC_TEST

Continuous glucose monitoring

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Miguel Angel Gomez Samano, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-27
Primary Completion
2021-03-06
Completion
2021-03-30

Countries

  • Mexico

Study Locations

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Diseases
Companies

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 NCT04090580 on ClinicalTrials.gov