Phase 3
Completed N=88
Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone
Source: ClinicalTrials.gov NCT04090580 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: ΔHbA1c — -1.8; -1.6 percentage of HbA1c
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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?
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 | — |
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.
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. Informational only — not medical advice.