Type 2 DiabetesPhase 4NCT05359432
Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus
A Phase 4 study testing Empagliflozin and Vildagliptin in people with Type 2 Diabetes, run by Getz Pharma at 1 site in Pakistan.
Trial summary
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus open labelled, multi-centric, parallel, randomized control trial In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Empagliflozin and Vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 18 Aug 2021
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".
- Uncontrolled type 2 diabetes mellitus (> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.
- BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2
Who cannot join
- Pregnant female or female patients planning to conceive during the study period were excluded from this study.
- "Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Diabetes and Endocrinology at Sindh Government Hospital New Karachi & Dr. Riasat Medical Center Allah Wala Town, Karachi, Pakistan
Karachi, Sindh, 75330
About this study
Official title: Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
open labelled, multi-centric, parallel, randomized control trial
In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \& safety parameters to be measured at both the baseline and 24-week visits.
Read the detailed description
Background:
Diabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it.
Objective:
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
Methods:
open labelled, multi-centric, parallel, randomized control trial to be conducted at the Department of Diabetes \& Endocrinology of two tertiary care hospitals in Karachi, Pakistan.
The Participants will undergo screening and then were randomized into two groups. The first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels., Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.
- Conditions
- Type 2 Diabetes
- Being tested
- Empagliflozin, Vildagliptin
- Keywords
- Type 2 Diabetes Mellitus, Empagliflozin, Vildagliptin, Efficacy, Safety
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Receiving allocated drug dosage as per clinical needs
VildagliptinDrug
Receiving allocated drug dosage as per clinical needs
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Not described Receives: Drug: Empagliflozin |
| Vildagliptin | Experimental | Not described Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin A1c (HbA1c)
Measured: 24 weeks
High-density lipoprotein (HDL) levels
Measured: 24 weeks
Systolic blood pressure
Measured: 24 weeks
Fasting blood sugars
Measured: 24 weeks
Bodyweight
Measured: 24 weeks
Serum creatinine
Measured: 24 weeks
Serum glutamic-pyruvic transaminase (SGPT)
Measured: 24 weeks
Low-density lipoprotein cholesterol
Measured: 24 weeks
Total cholesterols
Measured: 24 weeks
Serum triglycerides
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jul 2020
- Primary completion10 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jaffer Bin Baqar, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359432
- Sponsor's protocol ID
- AK_01
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data with CRF
Publications
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254-64. doi: 10.2522/ptj.20080020. Epub 2008 Sep 18.
PubMed 18801858American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.
PubMed 15618111Strodl E, Kenardy J. Psychosocial and non-psychosocial risk factors for the new diagnosis of diabetes in elderly women. Diabetes Res Clin Pract. 2006 Oct;74(1):57-65. doi: 10.1016/j.diabres.2006.02.011. Epub 2006 Apr 11.
PubMed 16584801Lin YK, Gao B, Liu L, Ang L, Mizokami-Stout K, Pop-Busui R, Zhang L. The Prevalence of Diabetic Microvascular Complications in China and the USA. Curr Diab Rep. 2021 Apr 9;21(6):16. doi: 10.1007/s11892-021-01387-3.
PubMed 33835284
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05359432
- Acronym / sponsor ID
- AK_01
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes Mellitus, Empagliflozin, Vildagliptin, Efficacy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 3 May 2022 (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 aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
open labelled, multi-centric, parallel, randomized control trial
In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \& safety parameters to be measured at both the baseline and 24-week visits.
Detailed description
Background:
Diabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it.
Objective:
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
Methods:
open labelled, multi-centric, parallel, randomized control trial to be conducted at the Department of Diabetes \& Endocrinology of two tertiary care hospitals in Karachi, Pakistan.
The Participants will undergo screening and then were randomized into two groups. The first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels., Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin |
| Vildagliptin | Experimental | Drug: Vildagliptin |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".
- Uncontrolled type 2 diabetes mellitus (> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.
- BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2
Key exclusion criteria (2 listed)
- Pregnant female or female patients planning to conceive during the study period were excluded from this study.
- "Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
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 |
|---|---|---|
| EmpagliflozinReceiving allocated drug dosage as per clinical needs | Drug | Empagliflozin |
| VildagliptinReceiving allocated drug dosage as per clinical needs | Drug | Vildagliptin |
Primary outcome
Glycosylated hemoglobin A1c (HbA1c)
Time frame: 24 weeks
High-density lipoprotein (HDL) levels
Time frame: 24 weeks
Systolic blood pressure
Time frame: 24 weeks
Fasting blood sugars
Time frame: 24 weeks
Bodyweight
Time frame: 24 weeks
Serum creatinine
Time frame: 24 weeks
Serum glutamic-pyruvic transaminase (SGPT)
Time frame: 24 weeks
Low-density lipoprotein cholesterol
Time frame: 24 weeks
Total cholesterols
Time frame: 24 weeks
Serum triglycerides
Time frame: 24 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 3 May 2022.
- Background: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background: PubMed 18801858Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254-64. doi: 10.2522/ptj.20080020. Epub 2008 Sep 18.
- Background: PubMed 15618111American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.
- Background: PubMed 16584801Strodl E, Kenardy J. Psychosocial and non-psychosocial risk factors for the new diagnosis of diabetes in elderly women. Diabetes Res Clin Pract. 2006 Oct;74(1):57-65. doi: 10.1016/j.diabres.2006.02.011. Epub 2006 Apr 11.
- Background: PubMed 33835284Lin YK, Gao B, Liu L, Ang L, Mizokami-Stout K, Pop-Busui R, Zhang L. The Prevalence of Diabetic Microvascular Complications in China and the USA. Curr Diab Rep. 2021 Apr 9;21(6):16. doi: 10.1007/s11892-021-01387-3.
- Individual participant dataSharing planned: Yes. Study data with CRF
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Vildagliptin in people with Type 2 Diabetes, run by Getz Pharma 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 2 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 3 May 2022. 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?
Glycosylated hemoglobin A1c (HbA1c) (time frame: 24 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359432, which also lists 5 linked publications.
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 3 May 2022.