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Completed

NCT Number: NCT07531108

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Galyawa Teaching Center for Diabetes and Endocrinology

Erbil, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin-Metformin

Drug

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

Sitagliptin-Metformin

Drug

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

metformin

Drug

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

Primary outcomes

  1. Change in serum omentin-1 concentrations from baseline to 12 weeks

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in serum omentin-1 concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA

  2. Change in serum resistin concentrations from baseline to 12 weeks

    Time frame: Baseline (pre- treatment) and week 12 (post-treatment)

    Mean change in serum resistin concentration (ng/mL) from baseline to 12 weeks in each treatment arm, measured by ELISA

Secondary outcomes

  1. Change in HbA1c from baseline to week 12

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in HbA1c (%) from baseline to week 12

  2. Change in fasting plasma glucose from baseline to week 12

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in fasting plasma glucose (mg/dL) from baseline to week 12 in each treatment arm

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

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in BMI (kg/m²) from baseline to week 12 in each treatment arm

  4. Change in body weight from baseline to week 12

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in body weight (Kg) from baseline to week 12 in each treatment arm

  5. Change in waist circumference from baseline to week 12

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in waist circumference (Cm) from baseline to week 12 in each treatment arm

  6. Change in waist-to-height ratio from baseline to week 12

    Time frame: Baseline (pre-treatment) and week 12 (post-treatment)

    Mean change in waist-to-height ratio from baseline to week 12 in each treatment arm (unitless)

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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