Glucose Metabolism DisordersPhase 4NCT06145360
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
A Phase 4 study testing Empagliflozin 10 MG and Insulin+Metformin+DPP4 inhibitor (DPP4I) in people with Glucose Metabolism Disorders and Diabetes Mellitus, Type 2, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Hypoglycemic Agents
- What is being tested?
- Empagliflozin 10 MG and Insulin+Metformin+DPP4 inhibitor (DPP4I)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
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
- Being tested
- Empagliflozin 10 MG, Insulin+Metformin+DPP4 inhibitor (DPP4I)
- Keywords
- Insulin Resistance, Type 2 Diabetes, Overweight, Add-on therapy, Glycemic control
- Medical subject headings
- Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Insulin Resistance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called EMPAA
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
Insulin+Metformin+DPP4 inhibitor (DPP4I)Drug
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 10mg | Experimental | Group A: Empagliflozin 10 mg once daily with antidiabetic drugs Receives: 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. Receives: Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
Weight in Kg
Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime
Measured: 12 weeks
BMI in kg/m2
Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime
Measured: 12 weeks
systolic blood pressure and diastolic blood pressure
systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- SINA Health Education and Welfare Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon Pharmaceutical Pvt Ltd
- Responsible party
- Sponsor
- Investigators
- Hina Sharif, Pharm-D,MSPH, Principal investigator, SINA Health Education & Welfare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145360
- Sponsor's protocol ID
- 00003
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06145360
- Acronym / sponsor ID
- 00003
- Conditions
- Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Hypoglycemic Agents, Empagliflozin
- Keywords
- Insulin Resistance, Type 2 Diabetes, Overweight, Add-on therapy, Glycemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SINA Health Education and Welfare TrustUniversity, hospital or other
- Collaborators
- Horizon Pharmaceutical Pvt Ltd
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10mg | Experimental | Drug: Empagliflozin 10 MGGroup A: Empagliflozin 10 mg once daily with antidiabetic drugs |
| regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) | Active comparator | Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)Group B: usual care group [Insulin+Metformin+DPP4 inhibitor (DPP4I)] but without Empagliflozin with adjustment of therapy as the standard of care. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: EMPAAthe 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 | Drug | Empagliflozin 10mg |
| Insulin+Metformin+DPP4 inhibitor (DPP4I)Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care | Drug | regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) |
Primary outcome
Number of participants achieved HbA1c level i.e. <7%
Time frame: 12 weeks
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
3 secondary outcomes
Weight in Kg
Time frame: 12 weeks
BMI in kg/m2
Time frame: 12 weeks
systolic blood pressure and diastolic blood pressure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hina Sharif, Pharm-D,MSPH principal investigator
SINA Health Education & Welfare Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG and Insulin+Metformin+DPP4 inhibitor (DPP4I) in people with Glucose Metabolism Disorders and Diabetes Mellitus, Type 2, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieved HbA1c level i.e. <7% (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.