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

NCT05359341 | Completed

• 1 other identifier: 09/2020
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabete Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The decrease in the body weight in patients in sitagliptin group versus empagliflozin group

  After completion of the study (One year anticipated)

• The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group

  After completion of the study (One year anticipated)

• The change in lipid profile in patients in sitagliptin group versus empagliflozin group

  After completion of the study (One year anticipated)

Other Outcomes (1)

• Percentage of adverse effects appeared in patients in sitagliptin group versus percentage of adverse effects appear in patients in the empagliflozin group.

  After completion of the study (One year anticipated)

Study Arms (4)

Sitagliptin 50 mg twice daily

ACTIVE COMPARATOR

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

Empagliflozin 12.5 twice daily

ACTIVE COMPARATOR

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

Sitagliptin 50 mg + empagliflozin 12.5 mg

ACTIVE COMPARATOR

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

Empagliflozin 12.5 + sitagliptin 50mg

ACTIVE COMPARATOR

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

Interventions

Sitagliptin 50 mg DRUG

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.

Also known as: DPP4 inhibitor

Sitagliptin 50 mg twice daily

Empagliflozin 12.5 MG DRUG

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.

Also known as: SGLT2 inhibitor

Empagliflozin 12.5 twice daily

Sitagliptin 50 mg + Empagliflozin 12.5 MG DRUG

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

Also known as: DPP4 inhibitor + SGLT2 inhibitor

Sitagliptin 50 mg + empagliflozin 12.5 mg

Empagliflozin 12.5 MG + Sitagliptin 50 mg DRUG

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

Also known as: SGLT2 inhibitor + DPP4 inhibitor

Empagliflozin 12.5 + sitagliptin 50mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 male/female diabetic patients
• Age 20-70 years
• A1C less than 10.5%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sadat City University: lead
• Beni-Suef University: collaborator

Study Sites (1)

University of Sadat City

El Sadat, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors; empagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant (MSC) in Clinical Pharmacy Department

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 3, 2022
• Study Start: September 20, 2020
• Primary Completion: September 20, 2021
• Study Completion: January 10, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)