NCT06145360CompletedPhase 4
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
Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 8 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 17 Nov 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- SINA Health Education and Welfare Trust
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06145360
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 150
- From 1 Dec 2023 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.
Other illness
- Patients with a history of recurrent urinary tract infections
Lab values
- patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m²,
Other
- those who are currently pregnant are excluded from participation in the study.
Who the study is looking for
- 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.
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SINA Shireen Jinnah colony Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.