Trial Outcomes & Findings for Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone (NCT NCT04090580)
NCT ID: NCT04090580
Last Updated: 2025-05-22
Results Overview
Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
88 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-05-22
Participant Flow
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.
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
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
46
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone
Baseline characteristics by cohort
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
50.9 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
52 years
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
42 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
MAGE mmol/L
|
4.3 mmol/L
STANDARD_DEVIATION 1.2 • n=93 Participants
|
4.1 mmol/L
STANDARD_DEVIATION 1.5 • n=4 Participants
|
4.2 mmol/L
STANDARD_DEVIATION 1.3 • n=27 Participants
|
|
weight kg
|
81.3 kg
STANDARD_DEVIATION 19.1 • n=93 Participants
|
80.0 kg
STANDARD_DEVIATION 13.9 • n=4 Participants
|
80.5 kg
STANDARD_DEVIATION 16 • n=27 Participants
|
|
HbA1c%
|
9.2 %
STANDARD_DEVIATION 1.6 • n=93 Participants
|
9.4 %
STANDARD_DEVIATION 1.3 • n=4 Participants
|
9.3 %
STANDARD_DEVIATION 1.4 • n=27 Participants
|
|
insulin µU/mL
|
12.2 µU/mL
STANDARD_DEVIATION 13.3 • n=93 Participants
|
10.9 µU/mL
STANDARD_DEVIATION 6.6 • n=4 Participants
|
11 µU/mL
STANDARD_DEVIATION 9 • n=27 Participants
|
|
triglycerides mg/dL
|
193 mg/dL
n=93 Participants
|
185.5 mg/dL
n=4 Participants
|
190 mg/dL
n=27 Participants
|
|
uric acid mg/dL
|
5.7 mg/dL
STANDARD_DEVIATION 1.3 • n=93 Participants
|
5.4 mg/dL
STANDARD_DEVIATION 1.4 • n=4 Participants
|
5.5 mg/dL
STANDARD_DEVIATION 1.3 • n=27 Participants
|
|
SBP mm/Hg
|
136.1 mm/Hg
STANDARD_DEVIATION 21.8 • n=93 Participants
|
130.8 mm/Hg
STANDARD_DEVIATION 16.6 • n=4 Participants
|
133 mm/Hg
STANDARD_DEVIATION 18 • n=27 Participants
|
|
TIR %target 70-180 mg/dL
|
55.5 %
n=93 Participants
|
82.7 %
n=4 Participants
|
69.1 %
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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
Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
ΔHbA1c
|
-1.8 percentage of HbA1c
Interval -3.0 to -0.5
|
-1.6 percentage of HbA1c
Interval -2.9 to 0.0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
ΔMAGE
|
-0.8 mmol/dL
Interval -1.6 to 0.0
|
0.0 mmol/dL
Interval -1.1 to 0.6
|
PRIMARY outcome
Timeframe: 12 weeksThe difference between weight before the treatment period (W0) and the end of the intervention is calculated and expressed as delta for results interpretation.
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
Δweight
|
-2.7 kg
Interval -4.4 to -1.4
|
-0.7 kg
Interval -2.6 to 0.55
|
PRIMARY outcome
Timeframe: 12 weeksTime in range is defined as the percentage of time that the patient's blood glucose is between 70-180 mg/dL.
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
ΔTIR %Target 70-180 mg/dL
|
31.5 percentage of time
Interval 3.6 to 72.3
|
0.4 percentage of time
Interval -8.5 to 39.2
|
PRIMARY outcome
Timeframe: 12 weeksDelta insulin is defined as the difference in insulin plasma concentration before treatment (W0) and at the end of the intervention (W12).
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
Δinsulin
|
-2.5 uU/mL
Interval -4.5 to -0.6
|
0.4 uU/mL
Interval -1.0 to 4.5
|
PRIMARY outcome
Timeframe: 12 weeksIt is defined as the difference in systolic blood pressure before treatment (W0) and after the end of intervention (W12)
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
Δsystolic Blood Pressure
|
-2.0 mm/Hg
Interval -15.0 to 5.0
|
0.0 mm/Hg
Interval -13.0 to 15.0
|
PRIMARY outcome
Timeframe: 12 weeksIt is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0)
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
ΔTriglycerides mg/dL
|
-50.5 mg/dL
Interval -103.0 to 2.2
|
-21.5 mg/dL
Interval -680.0 to 23.0
|
SECONDARY outcome
Timeframe: 12 weeksIt is defined as the difference in plasma uric acid concentration before and at the end of intervention (W12-W0)
Outcome measures
| Measure |
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
n=42 Participants
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).
|
METFORMIN 2000 mg/Day for 12 Weeks
n=46 Participants
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).
|
|---|---|---|
|
ΔUric Acid
|
-0.4 mg/dL
Interval -1.4 to 0.0
|
0.0 mg/dL
Interval -0.2 to 0.6
|
Adverse Events
DAPAGLIFLOZIN 10 mg/Day + METFORMIN 2000 mg/Day for 12 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
METFORMIN 2000 mg/Day for 12 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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
Phone: +52 1 55 59939816
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place