Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by AntipsychoticsPhase 3NCT05669742

Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients

A Phase 3 study testing Empagliflozin and olanzapine in people with Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics, run by Tanta University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Olanzapine is a thieno-benzodiazepine derivate that is effective managing the symptoms of schizophrenia and reducing the psychopathological symptoms of psychosis. It is also effective in controlling the acute manic episodes associated with bipolar disorder, and have provided some therapeutic advantages over other… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
What is being tested?: Empagliflozin and olanzapine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteEgypt
Study dates: 25 May 2023to Dec 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Schizophrenia Patients treated with Olanzapine with ages ranging from 18 to 60 years.

Who cannot join

patients who had any other inflammatory disease (cardiovascular, asthma, bone

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting

Tanta Unuversity
Tanta, 34518
Eman Elberri, PhD, 01067831661, eman.elberri@pharm.tanta.edu.eg
Recruiting

Other trials in Egypt

About this study

Official title: Evaluating the Safety and Efficacy of Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients.A Double-Blind, Randomized, Placebo-Controlled Trial

However, Ola administration has been reported to induce profound BWG accompanied with higher incidence of metabolic deficits, such as hypertension, diabetes and hyperlipidemia, as compared to other antipsychotic agents (Mauri et al., 2014).

Adjunctive treatment with other agents that can minimize or normalize Ola-induced BWG can enhance the safety and tolerability profiles of an effective antipsychotic, thus highlighting the need to develop improved therapies or interventions to minimize these side effects. A meta-analysis of 12 published studies found that antidiabetic drugs such as metformin improved metabolic parameters in patients treated with antipsychotics (de Silva et al., 2016).

These studies encouraged the evaluation of other antidiabetic agents as adjunctive therapies to minimize Ola-induced BWG. Empagliflozin (EMPA)is the third-generation anti-diabetic drug acting as sodium-glucose transport protein two inhibitor (SGLT2), which provides a new mechanism of action to improve glycemic control with modest decreases in systolic blood pressure and body weight (Pradhan et al., 2019). The effects of EMPA on Ola-induced BWG have not been determined and require further investigation.

Conditions: Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
Being tested: Empagliflozin, olanzapine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EmpagliflozinDrug
sodium-glucose transport protein two inhibitor
olanzapineDrug
antipsychotics

Study groups in NCT05669742
Study group	Role	What they receive
Group 1 as control group	Active comparator	Not described Receives: Drug: olanzapine
Group two as Empagliflozin	Active comparator	Not described Receives: Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in body weight and body mass index (BMI)
a person's weight in kilograms (or pounds) divided by the square of height in meters and measure of body fat based on height and weight that applies to adult men and women body mass index = wt (kilogram) divideed by height in meter square
Measured: up to 12 weeks

Secondary outcomes (1)

Adverse events (AE) as measures of safety and tolerability of Empagliflozin
any side effects of the used intervention
Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 2023Dec 2026

First posted3 Jan 2023
Study start25 May 2023
Primary completionJun 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by AntipsychoticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05669742
Sponsor's protocol ID: EMPA2022
Status last verified: Feb 2026
First submitted: 20 Dec 2022
Last updated: 6 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No