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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ΔHbA1c | Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage. | 12 weeks |
| ΔMAGE | ● Calculation of Mean Amplitude of Glucose Excursion (MAGE):
| 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. | 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. | 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). | 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) | 12 weeks |
| ΔTriglycerides mg/dL |
| Measure | Description | Time Frame |
|---|---|---|
| ΔUric Acid | It is defined as the difference in plasma uric acid concentration before and at the end of intervention (W12-W0) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Angel Gomez Samano, MD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ'' | Mexico City | 14080 | Mexico |
Participants were identified with name and last names initials
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Treatment: subjects who met the pre-randomization period and tolerated treatment were randomized 1:1 to receive either DAPA 10 mg/day + MET 2000 mg/day or MET 2000 mg/day for 12 weeks.
Of the total of 264 patients surveyed, a sample of 88 met the inclusion criteria and none of the exclusion criteria randomization DAPA+MET n=42 and MET n= 46
Patient recruitment began in October 2019 and was interrupted due to the SARS-COV-2 pandemic in March 2020. Nevertheless, patients who were already enrolled were followed up. Recruitment was normally restarted in March 2021; one of the inclusion criteria was adjusted, allowing HbA1c <13.0%, prior limit <12.0%. The last patient was recruited on December 6th, 2021.The complete study was concluded on March 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks | Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks 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 (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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2021 | May 1, 2025 |
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Evaluation of efficacy between Dapagliflozin with Metformin (Intervention) vs Metformin alone (Standard of care)
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It is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0) |
| 12 weeks |
| FG001 | METFORMIN 2000 mg/Day for 12 Weeks | Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 2000 mg metformin for 12 weeks 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 (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). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks | Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks 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 (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). |
| BG001 | METFORMIN 2000 mg/Day for 12 Weeks | Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 2000 mg metformin for 12 weeks 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 (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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| MAGE mmol/L | Mean | Standard Deviation | mmol/L |
| |||||||||||||||||
| weight kg | Mean | Standard Deviation | kg |
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| HbA1c% | Mean | Standard Deviation | % |
| |||||||||||||||||
| insulin µU/mL | Mean | Standard Deviation | µU/mL |
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| triglycerides mg/dL | Mean | Inter-Quartile Range | mg/dL |
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| uric acid mg/dL | Mean | Standard Deviation | mg/dL |
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| SBP mm/Hg | Mean | Standard Deviation | mm/Hg |
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| TIR %target 70-180 mg/dL | Mean | Inter-Quartile Range | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ΔHbA1c | Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage. | In the intention to treat analysis (ITT), early T2DM treatment with DAPA+MET (n=42) resulted in significant improvements in several health indicators compared to patients in the MET group (n=46). Results are presented as Δ, which represents the change between W0 and W12 values | Posted | Mean | Inter-Quartile Range | percentage of HbA1c | 12 weeks |
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| Primary | ΔMAGE | ● Calculation of Mean Amplitude of Glucose Excursion (MAGE):
| Posted | Mean | Inter-Quartile Range | mmol/dL | 12 weeks |
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| Primary | 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. | Posted | Mean | Inter-Quartile Range | kg | 12 weeks |
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| Primary | 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. | Posted | Mean | Inter-Quartile Range | percentage of time | 12 weeks |
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| Primary | Δinsulin | Delta insulin is defined as the difference in insulin plasma concentration before treatment (W0) and at the end of the intervention (W12). | Posted | Mean | Inter-Quartile Range | uU/mL | 12 weeks |
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| Primary | Δsystolic Blood Pressure | It is defined as the difference in systolic blood pressure before treatment (W0) and after the end of intervention (W12) | Posted | Mean | Inter-Quartile Range | mm/Hg | 12 weeks |
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| Primary | ΔTriglycerides mg/dL | It is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0) | Posted | Mean | Inter-Quartile Range | mg/dL | 12 weeks |
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| Secondary | ΔUric Acid | It is defined as the difference in plasma uric acid concentration before and at the end of intervention (W12-W0) | Posted | Mean | Inter-Quartile Range | mg/dL | 12 weeks |
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From the start of the intervention until the end of treatment, 12 weeks.
Number of participants at risk for Serious Adverse Events: 88 participants Number of participants at risk for All-Cause Mortality: 88 participants Number of participants at risk for Other Adverse Events: 88 participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks | Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks 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 (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). | 0 | 42 | 0 | 42 | 0 | 42 |
| EG001 | METFORMIN 2000 mg/Day for 12 Weeks | Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 2000 mg metformin for 12 weeks 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 (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). | 0 | 46 | 0 | 46 | 0 | 46 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miguel Ángel Gómez Sámano | Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán". Vasco de Quiroga 15, Belisario Domínguez Secc 16, Tlalpan, 14080, CDMX, Mexico. Department of endocrinology and lipid metabolism | +52 1 55 59939816 | miguel.gomezs@incmnsz.mx |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2021 | May 19, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2021 | May 19, 2025 | ICF_004.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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Subjects enrolled will be randomized 1:1 to either receive a daily dosage of 2000 mg metformin for 12 weeks
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 (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).
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