The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic Patients .

Bahria University

Status and phase: Completed; Phase 4

Conditions: Diabete Mellitus

Treatments: Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg); Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07247656

ERC 105/2022

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group B received Empagliflozin with Linagliptin

Active Comparator group

Description:

Empagliflozin 10 mg, along with Tab Linagliptin 5mg.

Treatment:

Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg)

Group A received Empagliflozin with Metformin

Active Comparator group

Description:

Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg

Treatment:

Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg