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

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

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

Study Overview

• Status: Completed
• Conditions: Diabete Type 2
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Sadat, Egypt
    • University of Sadat City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sitagliptin 50 mg twice daily; 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; 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.; Other Names: DPP4 inhibitor
Active Comparator: Empagliflozin 12.5 twice daily; 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; 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.; Other Names: SGLT2 inhibitor
Active Comparator: 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.	Drug: 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%); Other Names: DPP4 inhibitor + SGLT2 inhibitor
Active Comparator: Empagliflozin 12.5 + sitagliptin 50mg; 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; Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%); Other Names: SGLT2 inhibitor + DPP4 inhibitor

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Sadat City University
• Collaborators: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Empagliflozin; Sitagliptin Phosphate; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: 09/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No