Status:
COMPLETED
Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief 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 pr...
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 D...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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.
Key Trial Info
Start Date :
October 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04090580
Start Date
October 27 2019
End Date
March 30 2021
Last Update
May 22 2025
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''
Mexico City, Mexico, 14080