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The goal of this clinical trial is - Comparison of Empagliflozin - Linagliptin with Empagliflozin - Metformin combination therapy in reduction of body weight in T2DM Patients and it included 200 diabetic subjects with total study period of 12 weeks and individual study period of 4 weeks .
The goal of this clinical trial is to evaluate the safety and efficacy of both the drugs combination in evaluating weight loss and glycemic parameters .
SPSS version 25 will be used to generate the descriptive statistics. Frequency and percentage figures will be used to represent the qualitative factors.
The comparison will be done between male of group A with male of group B and female of group A with female of group B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B received Empagliflozin with Linagliptin | Active Comparator | Empagliflozin 10 mg, along with Tab Linagliptin 5mg. |
|
| Group A received Empagliflozin with Metformin | Active Comparator | Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Empagliflozin 10 mg+ Tab Linagliptin 5mg) | Drug | (Empagliflozin 10 mg+ Tab Linagliptin 5mg)was given once Orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall improvement in Fasting Blood Glucose | Fasting Blood glucose ( mg / dl ) was measured using Glucometer | 12 weeks |
| Overall change in Body Mass Index ( kg/m2) | Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape . | 12 weeks |
| Overall improvement in Random Blood Glucose | Random Blood Glucose was measured in mg/dl using Glucometer | 12 weeks |
| Over all improvement in Glycated Hemoglobin ( HbA1c) | Blood sample was taken to assess HbA1c | 12 weeks |
| Overall change in Waist to Hip Ratio | Measuring tape was used to measure | 12 weeks |
| Overall change in Waist Circumference | Was measured in inches using measuring tape | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To observe adverse effects in treatment groups |
| 12 weeks |
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Inclusion Criteria:
• Diabetic men and women of age 40-70 yrs.
Exclusion Criteria:
Male and female type 1 diabetic patients with BMI <25
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| Name | Affiliation | Role |
|---|---|---|
| NABILA RAFI | DOCTOR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahria University | Karachi | Sindh | Pakistan |
All collected IPD data will be shared
1 year after article publication
Access to all
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The patients was be divided two groups on the basis of their treatment option; group A Empagliflozin with Linagliptin group B Empagliflozin with Metformin
The study was be ethically approved by the Bahria University ethical review committee (BUMDC). Informed consent was taken before initiating the clinical trial in male and female diabetic patients.
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|
| Tab Empagliflozin 10 mg + Tab Metformin 500 mg | Drug | Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg |
|
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000069476 | Linagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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