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

April 27, 2022 updated by: Haitham Galal, Sadat City University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group
Time Frame: After completion of the study (One year anticipated)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The decrease in the body weight in patients in sitagliptin group versus empagliflozin group
Time Frame: After completion of the study (One year anticipated)
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
Time Frame: After completion of the study (One year anticipated)
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
Time Frame: After completion of the study (One year anticipated)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
Time Frame: After completion of the study (One year anticipated)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sadat City University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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