Effects of Empagliflozin-Metformin, Sitagliptin-Metformin, and Metformin on Adipokines in Type 2 Diabetes

Sponsor
Hawler Medical University
Study ID
NCT07531108
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin-Metformin — DRUG
    Oral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.
  • Sitagliptin-Metformin — DRUG
    Oral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus.
  • Metformin — DRUG
    Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.

Study Details

This study compared the impacts of empagliflozin-metformin, sitagliptin-metformin, and metformin monotherapy in treatment-naive overweight or obese adults with newly diagnosed type 2 diabetes mellitus in Erbil, Iraq. The study monitored participants for 12 weeks. It determined changes in serum omentin-1, resistin, glycemic markers, and anthropometric measures.

Key Dates

Start date
Nov 15, 2024
Status verified
Apr 2026
Primary completion
Nov 27, 2025
Completion
Nov 27, 2025

Study Design

Enrollment
186 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin-Metformin
    Empagliflozin plus metformin administered as standard oral doses for 12 weeks in adults with type 2 diabetes mellitus to evaluate effects on adipokines and glycemic control.
  • Active Comparator: Sitagliptin-Metformin
    Sitagliptin plus metformin administered as standard oral doses for 12 weeks in adults with type 2 diabetes mellitus to evaluate effects on adipokines and glycemic control.
  • Active Comparator: Metformin Monotherapy
    Metformin alone administered as standard oral doses for 12 weeks in adults with type 2 diabetes mellitus to evaluate effects on adipokines and glycemic control.

Primary Outcome Measure

Change in serum omentin-1 concentrations from baseline to 12 weeks [ Time Frame: Baseline (pre-treatment) and week 12 (post-treatment) ]

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