Phase 3 N=88 Randomized Treatment

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

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT04090580 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: ΔHbA1c — -1.8; -1.6 percentage of HbA1c

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Continuous glucose monitoring (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY ΔHbA1c	-1.8; -1.6	—
PRIMARY ΔMAGE	-0.8; 0.0	—
PRIMARY Δweight	-2.7; -0.7	—
PRIMARY ΔTIR %Target 70-180 mg/dL	31.5; 0.4	—
PRIMARY Δinsulin	-2.5; 0.4	—
PRIMARY Δsystolic Blood Pressure	-2.0; 0.0	—
PRIMARY ΔTriglycerides mg/dL	-50.5; -21.5	—
SECONDARY ΔUric Acid	-0.4; 0.0	—

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?

Eligibility Criteria

Inclusion Criteria

Subjects > 18-77 years-old
Both Male and female
Hba1c ≥ 7.5 % and ≤12%
BMI > 25 and 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04090580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.