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

Sadat City University

Status: Completed

Conditions: Diabete Type 2

Treatments: Drug: Empagliflozin 12.5 MG; Drug: Sitagliptin 50 mg + Empagliflozin 12.5 MG; Drug: Empagliflozin 12.5 MG + Sitagliptin 50 mg; Drug: Sitagliptin 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05359341

09/2020

Details and patient eligibility

About

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

Enrollment: 175 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 4 patient groups

Sitagliptin 50 mg twice daily

Active Comparator group

Description:

sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs.

Treatment:

Drug: Sitagliptin 50 mg

Empagliflozin 12.5 twice daily

Active Comparator group

Description:

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.

Treatment:

Drug: Empagliflozin 12.5 MG

Sitagliptin 50 mg + empagliflozin 12.5 mg

Active Comparator group

Description:

empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks.

Treatment:

Drug: Sitagliptin 50 mg + Empagliflozin 12.5 MG

Empagliflozin 12.5 + sitagliptin 50mg

Active Comparator group

Description:

sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks.

Treatment:

Drug: Empagliflozin 12.5 MG + Sitagliptin 50 mg