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

Sadat City University175 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Diabete Type 2

Interventions

Sitagliptin 50 mgDRUG

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.

Empagliflozin 12.5 MGDRUG

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.

Sitagliptin 50 mg + Empagliflozin 12.5 MGDRUG

Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Sadat City

El Sadat, Egypt

Outcomes

Primary Outcomes

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).

Time frame: After completion of the study (One year anticipated)

Secondary Outcomes

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.

Time frame: 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

Time frame: 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).

Time frame: After completion of the study (One year anticipated)

Data from ClinicalTrials.gov

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