Diabete Mellitus
Conditions
Keywords
liver profile, BMI, Waist to Hip Ratio, Renal Function tests, HBA1C
Brief summary
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 .
Detailed description
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.
Interventions
DRUG(Empagliflozin 10 mg+ Tab Linagliptin 5mg)
(Empagliflozin 10 mg+ Tab Linagliptin 5mg)was given once Orally daily
DRUGTab Empagliflozin 10 mg + Tab Metformin 500 mg
Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg
Sponsors
Bahria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Diabetic men and women of age 40-70 yrs. * HBA1C -(6.5-9 )percent * All diabetic patients were BMI ≥25kg/m2 * Patient took metformin ≥1000mg/day for ≥ 3 months with uncontrolled DM
Exclusion criteria
* Male and female type 1 diabetic patients with BMI \<25 * Diabetic patient taking oral medicine other than metformin for last 12 weeks * Subjects with creatinine \>1.5mg/dl * Pregnant or Lactating Women * Co-morbidities - * CLD * Cancer patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall improvement in Random Blood Glucose | 12 weeks | Random Blood Glucose was measured in mg/dl using Glucometer |
| Overall improvement in Fasting Blood Glucose | 12 weeks | Fasting Blood glucose ( mg / dl ) was measured using Glucometer |
| Overall change in Body Mass Index ( kg/m2) | 12 weeks | Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape . |
| Overall change in Waist Circumference | 12 weeks | Was measured in inches using measuring tape |
| Over all improvement in Glycated Hemoglobin ( HbA1c) | 12 weeks | Blood sample was taken to assess HbA1c |
| Overall change in Waist to Hip Ratio | 12 weeks | Measuring tape was used to measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To observe adverse effects in treatment groups | 12 weeks | 1. To evaluate any incidence of Hypoglycemic events during study period 2. To evaluate any incidence of Glycosuria during study period |
Countries
Pakistan
Outcome results
None listed