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

Diabete Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359341
• Other study ID #: 09/2020
• Status: Completed
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: April 2022
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 10, 2022
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Sitagliptin 50 mg
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 MG
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 MG
Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)
• Empagliflozin 12.5 MG + Sitagliptin 50 mg
Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)

Locations

Country	Name	City	State
Egypt	University of Sadat City	El Sadat

Sponsors (2)

Lead Sponsor	Collaborator
Sadat City University	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of adverse effects appeared in patients in sitagliptin group versus percentage of adverse effects appear in patients in the empagliflozin group.	AEs (n%) included all events with an onset after the first dose of open label emoagliflozin or sitagliptin and up to 7 days after the last dose of study drug. AEs of special interest included hypoglycaemia, genitourinary infections, hypersensitivity reactions, diabetic ketoacidosis, acute pancreatitis, hypotension, and dehydration. Confirmed hypoglycemic AEs were defined as events with a plasma glucose concentration of = 3.9 mmol/L.	After completion of the study (One year anticipated)
Primary	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	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)
Secondary	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)
Secondary	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)