Skip to main content
OpenTrials
Completed

NCT Number: NCT04090580

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

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Mexico City, 14080, Mexico

About this study

This is an open-label randomized clinical trial aimed to compare the effect of Dapagliflozin added to Metformin vs Metformin alone on glycemic variability of adults with a recent diagnosis of type 2 Diabetes. The central hypothesis is that the addition of Dapagliflozin will lead to a statistically significant improvement in GV parameters compared to Metformin alone. A total of 88 adults aged 18-70 years with T2DM and HbA1c between 7.5% and 12% while on a stable dose of Metformin 2000 mg/day will be enrolled. Participants will be randomized in a 1:1 ratio to one of two treatment arms for a duration of 12 weeks. The primary objective is to compare the change from baseline to end-of-treatment in key glycemic variability indices derived from continuous glucose monitoring (CGM) (Mean Amplitude Glucose Excursions -MAGE, Time in Range), changes in HbA1c, fasting blood glucose, lipid profile, BMI, blood pressure, among others.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects > 18-77 years-old
  • Both Male and female
  • Hba1c ≥ 7.5 % and ≤12%
  • BMI > 25 and <45 kg/m2
  • Type 2 diabetes diagnosis, drug-naive

Exclusion criteria

  • Hba1c > 12%
  • 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 enrollment, as assessed by the investigator
  • For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

Treatment and study plan

Continuous glucose monitoring

Diagnostic Test

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).

Primary outcomes

  1. ΔHbA1c

    Time frame: 12 weeks

    Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.

  2. ΔMAGE

    Time frame: 12 weeks

    ● Calculation of Mean Amplitude of Glucose Excursion (MAGE):

    • In the first step, all local maximum/minimum values are determined.
    • The next step is an evaluation of maximum/minimum pairs against the standard deviation (SD).
    • If the difference from minimum to maximum is greater than the SD, this variation from the mean measurement is retained.
    • If the local maximum/minimum is less than 1 SD, it is excluded from further calculations.
    • These channels are retained and summed to achieve the MAGE

  3. Δweight

    Time frame: 12 weeks

    The difference between weight before the treatment period (W0) and the end of the intervention is calculated and expressed as delta for results interpretation.

  4. ΔTIR %Target 70-180 mg/dL

    Time frame: 12 weeks

    Time in range is defined as the percentage of time that the patient's blood glucose is between 70-180 mg/dL.

  5. Δinsulin

    Time frame: 12 weeks

    Delta insulin is defined as the difference in insulin plasma concentration before treatment (W0) and at the end of the intervention (W12).

  6. Δsystolic Blood Pressure

    Time frame: 12 weeks

    It is defined as the difference in systolic blood pressure before treatment (W0) and after the end of intervention (W12)

  7. ΔTriglycerides mg/dL

    Time frame: 12 weeks

    It is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0)

Secondary outcomes

  1. ΔUric Acid

    Time frame: 12 weeks

    It is defined as the difference in plasma uric acid concentration before and at the end of intervention (W12-W0)

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone: A Randomized Open Label Clinical Study. The MAGNNIFY Trial.

Acronym: MAGNNIFY

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2019
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.