Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin-Metformin | Drug | Oral empagliflozin in combination with metformin at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus. |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sedra Bahjat Ismail, M.Sc. candidate | Clinical pharmacy Department, College of Pharmacy, HMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galyawa Teaching Center for Diabetes and Endocrinology | Erbil | 44001 | Iraq |
Individual participant data will not be shared due to confidentiality and data-protection considerations.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014230 |
Not provided
Not provided
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
Not provided
Not provided
Open-label study; participants and investigators knew the assigned treatment.
Not provided
|
| Sitagliptin-Metformin | Drug | Oral sitagliptin in combination with metformin at standard approved doses, given for 12 weeks to adults with type 2 diabetes mellitus. |
|
|
| Metformin | Drug | Oral metformin monotherapy at standard approved doses, given for 3 months to adults with type 2 diabetes mellitus. |
|
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) |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |