Type 2Diabetieus Melitus
Conditions
Interventions
Dapagliflozin 10 mg orally once daily added to stable Metformin therapy
Placebo
Sponsors
Maha Hassan Ahmed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diagnostic criteria—defined as random plasma glucose >11.1 mmol/L, fasting plasma glucose >7.0 mmol/L, or HbA1c =6.5%—are eligible for participation. Eligible participants must be receiving metformin monotherapy at a stable dose (=1000 mg/day) for at least eight weeks prior to enrollment and must demonstrate willingness to begin dapagliflozin therapy as part of the trial. All participants must provide written informed consent and demonstrate adequate compliance during the single-blind placebo run-in period (=70% based on pill count) before randomization
Exclusion criteria
Exclusion criteria: patients will be excluded if they have type 1 diabetes mellitus, HbA1c =7%, or if they are currently using any antidiabetic therapy other than metformin. Additional exclusion criteria include congestive heart failure (NYHA class III or IV) , significant gastrointestinal disorders, chronic or recurrent urinary tract infections, liver cirrhosis, uncontrolled hypertension (>170/110 mmHg), use of systemic corticosteroids =10 mg prednisolone daily, end-stage renal disease requiring dialysis, or any condition that affects HbA1c accuracy (e.g., hemoglobinopathies, uremia, advanced liver disease). Pregnant or breastfeeding women, individuals with known hypersensitivity to dapagliflozin or metformin, those with alcohol abuse, poor compliance risk, inability to understand study procedures, or any condition that the investigator determines unsafe for participation are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at: Baseline (Week 0), Week 4, Week 8, Week 12, and Week 16. 2. Postprandial Glucose (PPG) Measured at: Baseline (Week 0) and Week 16. 3. Glycemic Variability (CGM parameters) Measured at: Week 0 (baseline), Month 1, Month 2, Month 3, Month 4 (Week 16). 4. Body Weight Measured at: Baseline, Week 4, Week 8, Week 12, and Week 16. 5. Blood Pressure (SBP/DBP) Measured at: Baseline, Week 4, Week 8, Week 12, and Week 16. 6. Lipid Profile (TC, LDL, HDL, TG) Measured at: Baseline and Week 16. 7. Renal Function (Creatinine, eGFR, UACR) Measured at: Baseline and Week 16. 8. Safety and Adverse Events Measured at: Each follow-up visit — Week 4, Week 8, Week 12, Week 16. 9. Hypoglycemia Episodes Measured continuously throughout the 16-week intervention period. 10. Genitourinary Infections / DKA / Dehydration Assessed at: Week 4, Week 8, Week 12, Week 16, and whenever symptoms occur. 11. Medication Adherence (Morisky Scale) Measured at: Week 4, Week 8, Week 12, Week 1 | — |
Countries
Sudan
Contacts
Public ContactMaha Hassan
Lecturer in Faculty of Pharmacy University of Gezira
Outcome results
None listed