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

April 11, 2026 updated by: Sedra Bahjat Ismail, Hawler Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline (pre-treatment) and week 12 (post-treatment)
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
Baseline (pre- treatment) and week 12 (post-treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline (pre-treatment) and week 12 (post-treatment)
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
Baseline (pre-treatment) and week 12 (post-treatment)
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
Baseline (pre-treatment) and week 12 (post-treatment)
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
Baseline (pre-treatment) and week 12 (post-treatment)
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
Baseline (pre-treatment) and week 12 (post-treatment)
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)
Baseline (pre-treatment) and week 12 (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hawler Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sedra Bahjat Ismail, M.Sc. candidate, Clinical pharmacy Department, College of Pharmacy, HMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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