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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Empagliflozin-Metformin; Drug: Sitagliptin-Metformin; Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iraq
  • Erbil, Iraq, 44001
    • Galyawa Teaching Center for Diabetes and Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 35 to 75 years.
• Newly diagnosed treatment-naive type 2 diabetes mellitus with no comorbidities
• HbA1c between 7% and 13%.
• Overweight or obese status, with BMI 25 to 45 kg/m².
• Waist circumference 94 to 130 cm for men or 80 to 130 cm for women.
• Waist-to-height ratio between 0.50 and 0.90.
• Willingness to provide written informed consent.

Exclusion Criteria:

• Clinically significant cardiovascular, renal, or hepatic disease.
• Hypertension.
• Pregnancy or breastfeeding.
• Untreated or unstable thyroid disorders.
• Active psychiatric illness or use of psychotropic medications.
• Use of drugs known to affect adipokine levels, including glucocorticoids, statins, anti- inflammatory agents, hormonal therapies, or weight-loss medications.
• Acute or ongoing infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Empagliflozin-Metformin; Oral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.; Other Names: Empagliflozin; Metformin
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.	Drug: Sitagliptin-Metformin; Oral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus.; Other Names: Sitagliptin; Metformin
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.	Drug: Metformin; Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum omentin-1 concentrations from baseline to 12 weeks	Mean change in serum omentin-1 concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA	Baseline (pre-treatment) and week 12 (post-treatment)
Change in serum resistin concentrations from baseline to 12 weeks	Mean change in serum resistin concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA	Baseline (pre- treatment) and week 12 (post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c from baseline to week 12	Mean change in HbA1c (%) from baseline to week 12	Baseline (pre-treatment) and week 12 (post-treatment)
Change in fasting plasma glucose from baseline to week 12	Mean change in fasting plasma glucose (mg/dL) from baseline to week 12 in each treatment arm	Baseline (pre-treatment) and week 12 (post-treatment)
Change in body mass index (BMI) from baseline to week 12	Mean change in BMI (kg/m²) from baseline to week 12 in each treatment arm	Baseline (pre-treatment) and week 12 (post-treatment)
Change in body weight from baseline to week 12	Mean change in body weight (Kg) from baseline to week 12 in each treatment arm	Baseline (pre-treatment) and week 12 (post-treatment)
Change in waist circumference from baseline to week 12	Mean change in waist circumference (Cm) from baseline to week 12 in each treatment arm	Baseline (pre-treatment) and week 12 (post-treatment)
Change in waist-to-height ratio from baseline to week 12	Mean change in waist-to-height ratio from baseline to week 12 in each treatment arm (unitless)	Baseline (pre-treatment) and week 12 (post-treatment)

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: Sedra Bahjat Ismail, M.Sc. candidate, Clinical pharmacy Department, College of Pharmacy, HMU

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): November 27, 2025
• Study Completion (Actual): November 27, 2025

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; Type 2 diabetes; Empagliflozin; Cardiometabolic risk; anti-inflammatory adipokines
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Pyrazines; Biguanides; Guanidines; Amidines; Drug Combinations; Triazoles; Sitagliptin Phosphate; Metformin; empagliflozin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination
• Other Study ID Numbers: 05022025-2-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to confidentiality and data-protection considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No