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

Sponsor
Sadat City University
Study ID
NCT05359341
Status
Completed

Conditions

  • Diabete Type 2

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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%)
  • 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%)

Study Details

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

Key Dates

Start date
Sep 20, 2020
Status verified
Apr 2022
Primary completion
Sep 20, 2021
Completion
Jan 10, 2022

Study Design

Enrollment
175 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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) ]

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