Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?

Study Overview
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Brief Summary
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Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.

Official Title
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Comparative Study of DPP-4 Inhibitors and SGLT-2 Inhibitors in Egyptian Diabetic Patients

Conditions
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Diabete Type 2

Intervention / Treatment
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* Drug: Sitagliptin 50 mg
* Drug: Empagliflozin 12.5 MG
* Drug: Sitagliptin 50 mg + Empagliflozin 12.5 MG
* Drug: Empagliflozin 12.5 MG + Sitagliptin 50 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 male/female diabetic patients Age 20-70 years A1C less than 10.5% Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin 50 mg twice daily<br>sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. | Drug: Sitagliptin 50 mg<br>* Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.<br>* Other names: DPP4 inhibitor;|
| Active Comparator: Empagliflozin 12.5 twice daily<br>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. | Drug: Empagliflozin 12.5 MG<br>* Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.<br>* Other names: SGLT2 inhibitor;|
| Active Comparator: Sitagliptin 50 mg + empagliflozin 12.5 mg<br>empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks. | Drug: Sitagliptin 50 mg + Empagliflozin 12.5 MG<br>* Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)<br>* Other names: DPP4 inhibitor + SGLT2 inhibitor;|
| Active Comparator: Empagliflozin 12.5 + sitagliptin 50mg<br>sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks. | Drug: Empagliflozin 12.5 MG + Sitagliptin 50 mg<br>* Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)<br>* Other names: SGLT2 inhibitor + DPP4 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group | 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). | After completion of the study (One year anticipated) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease in the body weight in patients in sitagliptin group versus empagliflozin group | The decreased in body weight (Kg) from the baseline measures after therapy. | After completion of the study (One year anticipated) | 
| The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group | decrease in blood pressure is defined as the decrease in SBP and/or DBP (mmHg) from the baseline measures after completing therapy | After completion of the study (One year anticipated) | 
| The change in lipid profile in patients in sitagliptin group versus empagliflozin group | 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). | After completion of the study (One year anticipated) |