Skip to main content
OpenTrials
Completed

NCT Number: NCT05359341

Which is Better to Start With DPP-4 Inhibitors or 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sadat City

El Sadat, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: DPP4 inhibitor

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.

Other names: SGLT2 inhibitor

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%)

Other names: DPP4 inhibitor + SGLT2 inhibitor

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%)

Other names: SGLT2 inhibitor + DPP4 inhibitor

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

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.

    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.

Sponsors and collaborators

Lead sponsor

Sadat City University

Other

Collaborators

  • Beni-Suef University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 3, 2022
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.