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

NCT07531108 | Completed Phase 4

• 1 other identifier: 05022025-2-2
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Empagliflozin; Cardiometabolic risk; anti-inflammatory adipokines; Type 2 diabetes; obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  Baseline (pre-treatment) and week 12 (post-treatment)

• Change in body mass index (BMI) from baseline to week 12

  Baseline (pre-treatment) and week 12 (post-treatment)

• Change in body weight from baseline to week 12

  Baseline (pre-treatment) and week 12 (post-treatment)

• Change in waist circumference from baseline to week 12

  Baseline (pre-treatment) and week 12 (post-treatment)

Study Arms (3)

Empagliflozin-Metformin

ACTIVE COMPARATOR

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

Sitagliptin-Metformin

ACTIVE COMPARATOR

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

Metformin Monotherapy

ACTIVE COMPARATOR

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

Interventions

Sitagliptin-Metformin DRUG

Oral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus.

Also known as: Sitagliptin; Metformin

Sitagliptin-Metformin

Metformin DRUG

Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.

Metformin Monotherapy

Empagliflozin-Metformin DRUG

Oral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.

Also known as: Empagliflozin; Metformin

Empagliflozin-Metformin

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Galyawa Teaching Center for Diabetes and Endocrinology

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

empagliflozin; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Sedra Bahjat Ismail, M.Sc. candidate

  Clinical pharmacy Department, College of Pharmacy, HMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study; participants and investigators knew the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student, Hawler Medical Univsersity

Model Details: Non-randomized, three-arm parallel trial in adults with type 2 diabetes evaluating the comparative effects of empagliflozin-metformin, sitagliptin-metformin, and metformin alone on adipokine and glycemic control

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 15, 2026
• Study Start: November 15, 2024
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)