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

NCT ID: NCT05359341

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2022-01-10

Brief Summary

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

Detailed Description

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Conditions

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Diabete Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sitagliptin 50 mg

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Empagliflozin 12.5 MG

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Sitagliptin 50 mg + Empagliflozin 12.5 MG

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Empagliflozin 12.5 MG + Sitagliptin 50 mg

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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%)

Intervention Type 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%)

Intervention Type DRUG

Other Intervention Names

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DPP4 inhibitor SGLT2 inhibitor DPP4 inhibitor + SGLT2 inhibitor SGLT2 inhibitor + DPP4 inhibitor

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role collaborator

Sadat City University

OTHER

Sponsor Role lead

Responsible Party

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Haitham Galal

Teaching assistant (MSC) in Clinical Pharmacy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Sadat City

El Sadat, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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09/2020

Identifier Type: -

Identifier Source: org_study_id

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