Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?
- Conditions
- Diabete Type 2
- Interventions
- Registration Number
- NCT05359341
- Lead Sponsor
- Sadat City University
- Brief Summary
Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- Type 2 male/female diabetic patients
- Age 20-70 years
- A1C less than 10.5%
- Type 1 diabetes; HbA1c > 10.5%
- Pregnancy
- Chronic liver disease
- Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
- High bilirubin
- Albumin < 3.5 g/dl
- INR >1-2 Diabetic ketoacidosis
- Urinary tract infection (UTI)
- Pancreatitis < 6 months prior to enrolment
- Renal impairment (creatinine clearance ≤50 ml/min)
- Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment
- Non-compliance with follow-up visits.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin 50 mg + empagliflozin 12.5 mg Sitagliptin 50 mg + Empagliflozin 12.5 MG empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks. Sitagliptin 50 mg twice daily Sitagliptin 50 mg sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. Empagliflozin 12.5 + sitagliptin 50mg Empagliflozin 12.5 MG + Sitagliptin 50 mg sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks. Empagliflozin 12.5 twice daily Empagliflozin 12.5 MG Empagliflozin 12.5 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs.
- Primary Outcome Measures
Name Time Method Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group After completion of the study (One year anticipated) The primary efficacy endpoint will be evaluated as clinical cure after 12 weeks of addition of sitagliptin or empagliflozin to metformin and after 12 weeks after adding empaglifozin to sitagliptin group and vise versa.
Clinical cure defined by A1C controlled (less than 7%), decrease in fasting and postprandial plasma glucose (mg/dl).
- Secondary Outcome Measures
Name Time Method The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group After completion of the study (One year anticipated) decrease in blood pressure is defined as the decrease in SBP and/or DBP (mmHg) from the baseline measures after completing therapy
The decrease in the body weight in patients in sitagliptin group versus empagliflozin group After completion of the study (One year anticipated) The decreased in body weight (Kg) from the baseline measures after therapy.
The change in lipid profile in patients in sitagliptin group versus empagliflozin group After completion of the study (One year anticipated) Change in lipid profile including decreasing in the following measures from the baseline measures after therapy is completed: low density lipoprotein (mg/dl), total cholesterol (mg/dl), triglyceride (mg/dl) and high density lipoprotein (mg/dl).
Trial Locations
- Locations (1)
University of Sadat City
🇪🇬El Sadat, Egypt