Diabetes Mellitus, Type 2Phase 4NCT07531108

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

A Phase 4 study testing Empagliflozin-Metformin, Sitagliptin-Metformin and Metformin in people with Diabetes Mellitus, Type 2, run by Hawler Medical University at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Empagliflozin-Metformin, Sitagliptin-Metformin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteIraq
Study dates: 15 Nov 2024to 27 Nov 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Iraq1 site

Galyawa Teaching Center for Diabetes and Endocrinology
Erbil, 44001

Other trials in Iraq

About this study

Official 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

Read the 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
Being tested: Empagliflozin-Metformin, Sitagliptin-Metformin, Metformin
Keywords: Empagliflozin, Cardiometabolic risk, anti-inflammatory adipokines, Type 2 diabetes, obesity
Medical subject headings: Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Empagliflozin-MetforminDrug
Also called Empagliflozin; Metformin
Oral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.
Sitagliptin-MetforminDrug
Also called Sitagliptin; Metformin
Oral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus.
MetforminDrug
Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.

Study groups in NCT07531108
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Change in HbA1c from baseline to week 12
Mean change in HbA1c (%) from baseline to week 12
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline (pre-treatment) and week 12 (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202427 Nov 2025

First posted15 Apr 2026
Study start15 Nov 2024
Primary completion27 Nov 2025
Study completion27 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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
Masking: None (open label)
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07531108
Sponsor's protocol ID: 05022025-2-2
Status last verified: Apr 2026
First submitted: 6 Apr 2026
Last updated: 15 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared due to confidentiality and data-protection considerations.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07531108
Acronym / sponsor ID: 05022025-2-2
Conditions: Diabetes Mellitus, Type 2
Keywords: Empagliflozin, Cardiometabolic risk, anti-inflammatory adipokines, Type 2 diabetes, obesity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: Hawler Medical UniversityUniversity, hospital or other
Study start: 15 Nov 2024 (actual)
Primary completion: 27 Nov 2025 (actual)
Study completion: 27 Nov 2025 (actual)
First posted: 15 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 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

Arm	Type	Receives
Empagliflozin-Metformin	Active comparator	Drug: Empagliflozin-MetforminEmpagliflozin 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.
Sitagliptin-Metformin	Active comparator	Drug: Sitagliptin-MetforminSitagliptin 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.
Metformin Monotherapy	Active comparator	Drug: MetforminMetformin alone administered as standard oral doses for 12 weeks in adults with type 2 diabetes mellitus to evaluate effects on adipokines and glycemic control.

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (7 listed)

Clinically significant cardiovascular, renal, or hepatic disease.
Hypertension.
Pregnancy or breastfeeding.
Untreated or unstable thyroid disorders.
Active psychiatric illness or use of psychotropic medications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Empagliflozin-MetforminAlso: Empagliflozin; MetforminOral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.	Drug	Empagliflozin-Metformin
Sitagliptin-MetforminAlso: Sitagliptin; MetforminOral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus.	Drug	Sitagliptin-Metformin
MetforminOral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus.	Drug	Metformin Monotherapy

Primary outcome

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
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

6 secondary outcomes

Change in HbA1c from baseline to week 12
Time frame: 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)
Change in body mass index (BMI) from baseline to week 12
Time frame: 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)
Change in waist circumference from baseline to week 12
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality and data-protection considerations.

Related trials for Diabetes Mellitus, Type 2

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Active, not recruiting
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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sedra Bahjat Ismail, M.Sc. candidate principal investigator

Clinical pharmacy Department, College of Pharmacy, HMU

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin-Metformin, Sitagliptin-Metformin and Metformin in people with Diabetes Mellitus, Type 2, run by Hawler Medical University at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum omentin-1 concentrations from baseline to 12 weeks (time frame: Baseline (pre-treatment) and week 12 (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07531108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.