NCT07531108

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

Effects of Empagliflozin-Metformin, Sitagliptin-Metformin, and Metformin on Serum Omentin 1 and Resistin in Treatment Naive Obese Patients With Type 2 Diabetes: A Clinical Prospective Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This protocol depicts a prospective, open-label, parallel-group clinical study determining the effects of empagliflozin-metformin, sitagliptin-metformin, and metformin monotherapy on circulating omentin-1 and resistin in treatment-naive overweight or obese patients with newly diagnosed type 2 diabetes mellitus in Erbil, Iraq. The trial enrolled 144 participants who were monitored for 12 weeks, with evaluation of serum adipokines, glycemic markers, and anthropometric variables at baseline and completion of follow-up. The primary objective was to examine the difference in serum omentin-1 and resistin among the three treatment regimens. Secondary outcomes involved changes in glycated hemoglobin, fasting blood sugar, body mass index, body weight, waist circumference and waist-to-height ratio. Serum omentin-1 and resistin were obtained using ELISA, while glycated hemoglobin was determined using an automated analyzer. Statistical analysis included descriptive methods and relevant within-group and between-group comparisons in accordance with data distribution. The study was conducted after ethics approval and written informed consent from each participants.

Conditions

• Diabetes Mellitus, Type 2

Interventions

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

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-11-27
• Completion: 2025-11-27
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Iraq