Type 2 DiabetesPhase 3MAGNNIFYNCT04090580
Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone
A Phase 3 study testing Continuous glucose monitoring in people with Type 2 Diabetes, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous glucose monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteMexico
- Study dates
- 27 Oct 2019to 30 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''
Mexico City, 14080
About this study
Official 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.
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?
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous glucose monitoring
- Keywords
- dapagliflozin, glycemic variability, MAGE, DIABETES MELLITUS
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| DAPAGLIFLOZIN 10 mg/day + METFORMIN 2000 mg/day for 12 weeks | Experimental | Subjects enrolled will be randomized 1:1 to receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks Receives: Diagnostic Test: Continuous glucose monitoring |
| METFORMIN 2000 mg/day for 12 weeks | Active comparator | Subjects enrolled will be randomized 1:1 to receive a daily dosage of 2000 mg Metformin for 12 weeks Receives: Diagnostic Test: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔHbA1c
Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.
Measured: 12 weeks
ΔMAGE
● 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
Measured: 12 weeks
Δweight
The difference between weight before the treatment period (W0) and the end of the intervention is calculated and expressed as delta for results interpretation.
Measured: 12 weeks
ΔTIR %Target 70-180 mg/dL
Time in range is defined as the percentage of time that the patient's blood glucose is between 70-180 mg/dL.
Measured: 12 weeks
Δinsulin
Delta insulin is defined as the difference in insulin plasma concentration before treatment (W0) and at the end of the intervention (W12).
Measured: 12 weeks
Δsystolic Blood Pressure
It is defined as the difference in systolic blood pressure before treatment (W0) and after the end of intervention (W12)
Measured: 12 weeks
ΔTriglycerides mg/dL
It is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0)
Measured: 12 weeks
Secondary outcomes (1)
ΔUric Acid
It is defined as the difference in plasma uric acid concentration before and at the end of intervention (W12-W0)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start27 Oct 2019
- Primary completion6 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of efficacy between Dapagliflozin with Metformin (Intervention) vs Metformin alone (Standard of care)
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Miguel Ángel Gómez Sámano, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Miguel Angel Gomez Samano, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090580
- Sponsor's protocol ID
- 3089
- Acronym
- MAGNNIFY
- Status last verified
- May 2025
- First submitted
- 11 Sep 2019
- Last updated
- 22 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants were identified with name and last names initials
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04090580
- Acronym / sponsor ID
- MAGNNIFY / 3089
- Conditions
- Type 2 Diabetes
- Keywords
- dapagliflozin, glycemic variability, MAGE, DIABETES MELLITUS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 22 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of efficacy between Dapagliflozin with Metformin (Intervention) vs Metformin alone (Standard of care)
| Arm | Type | Receives |
|---|---|---|
| DAPAGLIFLOZIN 10 mg/day + METFORMIN 2000 mg/day for 12 weeks | Experimental | Diagnostic Test: Continuous glucose monitoringSubjects enrolled will be randomized 1:1 to receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks |
| METFORMIN 2000 mg/day for 12 weeks | Active comparator | Diagnostic Test: Continuous glucose monitoringSubjects enrolled will be randomized 1:1 to receive a daily dosage of 2000 mg Metformin for 12 weeks |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringSubjects 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). | Diagnostic test | DAPAGLIFLOZIN 10 mg/day + METFORMIN 2000 mg/day for 12 weeks, METFORMIN 2000 mg/day for 12 weeks |
Primary outcome
ΔHbA1c
Time frame: 12 weeks
Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.
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
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.
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.
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).
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)
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)
1 secondary outcome
ΔUric Acid
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Participants were identified with name and last names initials
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Angel Gomez Samano, MD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous glucose monitoring in people with Type 2 Diabetes, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔHbA1c (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.