Diabete Type 2NCT05359341
Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?
A study testing Sitagliptin 50 mg, Empagliflozin 12.5 MG and Sitagliptin 50 mg + Empagliflozin 12.5 MG in people with Diabete Type 2, run by Sadat City University at 1 site in Egypt.
Trial summary
Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Sitagliptin 50 mg, Empagliflozin 12.5 MG and Sitagliptin 50 mg + Empagliflozin 12.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to 10 Jan 2022
- Phase
- Interventional
- 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
- Type 2 male/female diabetic patients
- Age 20-70 years
- A1C less than 10.5%
Who cannot join
- Type 1 diabetes; HbA1c > 10.5%
- Pregnancy
- Chronic liver disease
- Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
- High bilirubin
- Albumin < 3.5 g/dl
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- INR >1-2 Diabetic ketoacidosis
- Urinary tract infection (UTI)
- Pancreatitis < 6 months prior to enrolment
- Renal impairment (creatinine clearance ≤50 ml/min)
- Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment
- Non-compliance with follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of DPP-4 Inhibitors and SGLT-2 Inhibitors in Egyptian Diabetic Patients
Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.
- Conditions
- Diabete Type 2
- Being tested
- Sitagliptin 50 mg, Empagliflozin 12.5 MG, Sitagliptin 50 mg + Empagliflozin 12.5 MG, Empagliflozin 12.5 MG + Sitagliptin 50 mg
- 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.
Sitagliptin 50 mgDrug
Also called DPP4 inhibitor
Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
Empagliflozin 12.5 MGDrug
Also called SGLT2 inhibitor
Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
Sitagliptin 50 mg + Empagliflozin 12.5 MGDrug
Also called DPP4 inhibitor + SGLT2 inhibitor
Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)
Empagliflozin 12.5 MG + Sitagliptin 50 mgDrug
Also called SGLT2 inhibitor + DPP4 inhibitor
Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin 50 mg twice daily | Active comparator | sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. Receives: Drug: Sitagliptin 50 mg |
| Empagliflozin 12.5 twice daily | Active comparator | Empagliflozin 12.5 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. Receives: Drug: Empagliflozin 12.5 MG |
| Sitagliptin 50 mg + empagliflozin 12.5 mg | Active comparator | empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks. Receives: Drug: Sitagliptin 50 mg + Empagliflozin 12.5 MG |
| Empagliflozin 12.5 + sitagliptin 50mg | Active comparator | sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks. Receives: Drug: Empagliflozin 12.5 MG + Sitagliptin 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group
The primary efficacy endpoint will be evaluated as clinical cure after 12 weeks of addition of sitagliptin or empagliflozin to metformin and after 12 weeks after adding empaglifozin to sitagliptin group and vise versa.
Clinical cure defined by A1C controlled (less than 7%), decrease in fasting and postprandial plasma glucose (mg/dl).
Measured: After completion of the study (One year anticipated)
Secondary outcomes (3)
The decrease in the body weight in patients in sitagliptin group versus empagliflozin group
The decreased in body weight (Kg) from the baseline measures after therapy.
Measured: After completion of the study (One year anticipated)
The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group
decrease in blood pressure is defined as the decrease in SBP and/or DBP (mmHg) from the baseline measures after completing therapy
Measured: After completion of the study (One year anticipated)
The change in lipid profile in patients in sitagliptin group versus empagliflozin group
Change in lipid profile including decreasing in the following measures from the baseline measures after therapy is completed: low density lipoprotein (mg/dl), total cholesterol (mg/dl), triglyceride (mg/dl) and high density lipoprotein (mg/dl).
Measured: After completion of the study (One year anticipated)
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 start20 Sep 2020
- Primary completion20 Sep 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, Haitham Galal, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359341
- Sponsor's protocol ID
- 09/2020
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Comparative Study of DPP-4 Inhibitors and SGLT-2 Inhibitors in Egyptian Diabetic Patients
- ClinicalTrials.gov ID
- NCT05359341
- Acronym / sponsor ID
- 09/2020
- Conditions
- Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 10 Jan 2022 (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.
Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin 50 mg twice daily | Active comparator | Drug: Sitagliptin 50 mgsitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. |
| Empagliflozin 12.5 twice daily | Active comparator | Drug: Empagliflozin 12.5 MGEmpagliflozin 12.5 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. |
| Sitagliptin 50 mg + empagliflozin 12.5 mg | Active comparator | Drug: Sitagliptin 50 mg + Empagliflozin 12.5 MGempagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks. |
| Empagliflozin 12.5 + sitagliptin 50mg | Active comparator | Drug: Empagliflozin 12.5 MG + Sitagliptin 50 mgsitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 male/female diabetic patients
- Age 20-70 years
- A1C less than 10.5%
Key exclusion criteria (12 listed)
- Type 1 diabetes; HbA1c > 10.5%
- Pregnancy
- Chronic liver disease
- Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
- High bilirubin
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 |
|---|---|---|
| Sitagliptin 50 mgAlso: DPP4 inhibitorAdding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks. | Drug | Sitagliptin 50 mg twice daily |
| Empagliflozin 12.5 MGAlso: SGLT2 inhibitorAdding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks. | Drug | Empagliflozin 12.5 twice daily |
| Sitagliptin 50 mg + Empagliflozin 12.5 MGAlso: DPP4 inhibitor + SGLT2 inhibitorAdding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%) | Drug | Sitagliptin 50 mg + empagliflozin 12.5 mg |
| Empagliflozin 12.5 MG + Sitagliptin 50 mgAlso: SGLT2 inhibitor + DPP4 inhibitorAdding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%) | Drug | Empagliflozin 12.5 + sitagliptin 50mg |
Primary outcome
Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group
Time frame: After completion of the study (One year anticipated)
The primary efficacy endpoint will be evaluated as clinical cure after 12 weeks of addition of sitagliptin or empagliflozin to metformin and after 12 weeks after adding empaglifozin to sitagliptin group and vise versa. Clinical cure defined by A1C controlled (less than 7%), decrease in fasting and postprandial plasma glucose (mg/dl).
3 secondary outcomes
The decrease in the body weight in patients in sitagliptin group versus empagliflozin group
Time frame: After completion of the study (One year anticipated)
The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group
Time frame: After completion of the study (One year anticipated)
The change in lipid profile in patients in sitagliptin group versus empagliflozin group
Time frame: After completion of the study (One year anticipated)
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.
- Individual participant dataSharing planned: Yes
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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 study testing Sitagliptin 50 mg, Empagliflozin 12.5 MG and Sitagliptin 50 mg + Empagliflozin 12.5 MG in people with Diabete Type 2, run by Sadat City University at 1 site in Egypt.
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 12 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 Egypt. 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.
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?
Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group (time frame: After completion of the study (One year anticipated)). 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 3 May 2022.