Evaluating the Efficacy and Safety of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes and Obese Patient

NCT06145360 | Completed Phase 4 DMC

• 1 other identifier: 00003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.

Conditions

Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Empagliflozin

Keywords

Insulin Resistance; Type 2 Diabetes; Overweight; Add-on therapy; Glycemic control

Outcome Measures

Primary Outcomes (1)

• Number of participants achieved HbA1c level i.e. <7%

  The foremost objective is to determine whether the addition of Empagliflozin to the current treatment regimen leads to a significant improvement in glycemic control i.e. glycated haemoglobin less than 7% among poorly controlled T2DM patients in three months of treatment

  12 weeks

Secondary Outcomes (3)

• Weight in Kg

  12 weeks

• BMI in kg/m2

  12 weeks

• systolic blood pressure and diastolic blood pressure

  12 weeks

Study Arms (2)

Empagliflozin 10mg

EXPERIMENTAL

Group A: Empagliflozin 10 mg once daily with antidiabetic drugs

Drug: Empagliflozin 10 MG

regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)

ACTIVE COMPARATOR

Group B: usual care group \[Insulin+Metformin+DPP4 inhibitor (DPP4I)\] but without Empagliflozin with adjustment of therapy as the standard of care.

Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)

Interventions

Empagliflozin 10 MG DRUG

the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) in poorly controlled type 2 diabetes mellitus (T2DM

Also known as: EMPAA

Empagliflozin 10mg

Insulin+Metformin+DPP4 inhibitor (DPP4I) DRUG

Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 35 years or older, diagnosed with Type 2 Diabetes Mellitus,
• Specifically, individuals with a documented HbA1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates.
• these patients should currently be undergoing treatment involving a combination of Insulin and either Metformin or Sitagliptin.

You may not qualify if:

• Patients with a history of recurrent urinary tract infections
• those who are currently pregnant are excluded from participation in the study.
• patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m²,
• Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.

Sponsors & Collaborators

• SINA Health Education and Welfare Trust: lead
• Horizon Pharmaceutical Pvt Ltd: collaborator

Study Sites (1)

SINA Shireen Jinnah colony

Karachi, Pakistan

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Insulin Resistance; Overweight

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hina Sharif, Pharm-D,MSPH

  SINA Health Education & Welfare Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An adaptive research design was judiciously employed to navigate the complexities of this research. Leveraging a secondary dataset, the study engaged data from registered diabetic patients who had been consistently monitored by SINA over the past six months. These existing datasets formed the foundation for analysis, enabling informed decision-making. Based on rigorous analytical evaluations, a standardized treatment protocol was established, with patients prescribed Empagliflozin 10mg for a duration of three months

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)