Liver Cirrhosis With DiabetesPhase 4NCT07439536
Dose Optimization of Sitagliptin and Duloxetine in Diabetic Cirrhosis
A Phase 4 study testing Sitagliptin (Januvia), Sitagliptin (JANUVIA®) and Duloxetine (60 mg) once daily in people with Liver Cirrhosis With Diabetes, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on cirrhotic patients with diabetes mellitus and diabetic neuropathy, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis With Diabetes
- What is being tested?
- Sitagliptin (Januvia), Sitagliptin (JANUVIA®) and Duloxetine (60 mg) once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Oct 2025
- 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 18 to 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of cirrhosis.
- Diagnosed with diabetes mellitus.
- Presence of diabetic neuropathy.
- Age of patients > 18 years.
Who cannot join
- Patients with kidney disorder or dialysis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Model-Guided Dose Adjustment of Sitagliptin and Duloxetine Across Child-Pugh Classes Compared to Non-Cirrhotic Diabetic Patients
This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on cirrhotic patients with diabetes mellitus and diabetic neuropathy, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A , CP-B, and CP-C) in case of sitagliptin and CP-A in duloxetine at doses corresponding to the closest commercially available strengths to Simcyp®-optimized doses.
Clinical evaluation included glycemic parameters(HbA1C,fasting blood glucose,2-hr post prandial glucose level) and pain reduction. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT],and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]),and CBC.
Read the detailed description
This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on Egyptian cirrhotic patients with diabetes mellitus and diabetic neuropathy. Adult patients aged >18 years with confirmed liver cirrhosis, concomitant diabetes mellitus and diabetic neuropathy were eligible for inclusion. Patients were experienced acute episodes of disease associated with deterioration of hepatic function within 2 months prior to screening, and received concomitant medications known to strongly interact with the study drugs were excluded. In part 1: Sitagliptin dosing was determined based on Simcyp -generated predictions and clinical assessment. 100mg,100 mg, 50 mg, and 50 mg received by control, CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. In part 2: Duloxetine dosing was determined based on Simcyp-generated predictions and clinical assessment. 60 mg ,30 mg received by control, and CP-A cirrhotic patients orally once daily, respectively. Clinical evaluation included glycemic parameters(HbA1C,fasting blood glucose,2-hr post prandial glucose level) and pain reduction. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT],and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]),and CBC.
- Conditions
- Liver Cirrhosis With Diabetes
- Being tested
- Sitagliptin (Januvia), Sitagliptin (JANUVIA®), Duloxetine (60 mg) once daily, Duloxetine 30mg once daily
- Keywords
- Liver Cirrhosis, Diabetes, Sitagliptin, Duloxetine
- Medical subject headings
- Liver Cirrhosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin (Januvia)Drug
Diabetic patients with Child-Pugh class A hepatic cirrhosis receiving 100 mg model -informed adjusted dose of sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar.
Sitagliptin (JANUVIA®)Drug
Diabetic patients with Child-Pugh class C hepatic cirrhosis receiving 50 mg model -informed adjusted dose of sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar.
Sitagliptin (JANUVIA®)Drug
Diabetic patients with Child-Pugh class B hepatic cirrhosis receiving 50 mg model -informed adjusted dose of sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar.
Sitagliptin (JANUVIA®)Drug
Diabetic patients without hepatic cirrhosis receiving the standard recommended dose of 100 mg sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar.
Duloxetine (60 mg) once dailyDrug
Diabetic patients without hepatic cirrhosis receiving the standard recommended dose of 60 mg Duloxetine.
Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor, It has since received approval for a variety of indications including the treatment of neuropathic pain.
Duloxetine 30mg once dailyDrug
Diabetic patients with peripheral diabetic neuropathy and Child-Pugh class A hepatic cirrhosis receiving 30 mg model -informed adjusted dose of duloxetine. Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor, It has since received approval for a variety of indications including the treatment of neuropathic pain.
| Study group | Role | What they receive |
|---|---|---|
| Control -Standard Dose Sitagliptin | Active comparator | Sitagliptin (100 mg) Receives: Drug: Sitagliptin (JANUVIA®) |
| Child-Pugh A Sitagliptin | Experimental | CP-A: Sitagliptin 100 mg Receives: Drug: Sitagliptin (Januvia) |
| Child-Pugh B Sitagliptin | Experimental | CP-B: Sitagliptin 50 mg Receives: Drug: Sitagliptin (JANUVIA®) |
| Child-Pugh C Sitagliptin | Experimental | CP-C :Sitagliptin 50 mg Receives: Drug: Sitagliptin (JANUVIA®) |
| Control -Standard Dose Duloxetine | Active comparator | Duloxetine (60 mg) Receives: Drug: Duloxetine (60 mg) once daily |
| Child-Pugh A | Experimental | CP-A: 30 mg Duloxetine Receives: Drug: Duloxetine 30mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of diabetes mellitus and diabetic neuropathy
by measuring glycemic parameters ( fasting blood glucose level,2-hr postprandial glucose level) (mg/dL).
Measured: 3 months
Secondary outcomes (1)
Adverse Effects Monitoring
Adverse effects including headache, dry mouth, nasopharyngitis, dizziness, nausea, and diarrhea will be recorded
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Cirrhosis With DiabetesStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-assignment interventional study to compare dose-adjusted sitagliptin and duloxetine across Child-Pugh classes with standard-dose diabetic controls."
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Emad Nasr Mohammed Fouda, Kafrelsheikh University
- Investigators
- Noha Mahmoud ELkhodary, PhD, Study director, Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh UniversityAya Emad Fouda, MSc in Clinical Pharmacy, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439536
- Sponsor's protocol ID
- KFSIRB200-211/1
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Asakawa M, Mitsui H, Akihisa M, Sekine T, Niitsu Y, Kobayashi A, Miyake A, Hashimoto N, Kawamura M, Ogawa Y. Efficacy and safety of sitagliptin for the treatment of diabetes mellitus complicated by chronic liver injury. Springerplus. 2015 Jul 15;4:346. doi: 10.1186/s40064-015-1135-z. eCollection 2015.
PubMed 26191473
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Model-Guided Dose Adjustment of Sitagliptin and Duloxetine Across Child-Pugh Classes Compared to Non-Cirrhotic Diabetic Patients
- ClinicalTrials.gov ID
- NCT07439536
- Acronym / sponsor ID
- KFSIRB200-211/1
- Conditions
- Liver Cirrhosis With Diabetes
- Keywords
- Liver Cirrhosis, Diabetes, Sitagliptin, Duloxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 27 Feb 2026 (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.
This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on cirrhotic patients with diabetes mellitus and diabetic neuropathy, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A , CP-B, and CP-C) in case of sitagliptin and CP-A in duloxetine at doses corresponding to the closest commercially available strengths to Simcyp®-optimized doses.
Clinical evaluation included glycemic parameters(HbA1C,fasting blood glucose,2-hr post prandial glucose level) and pain reduction. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT],and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]),and CBC.
Detailed description
This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on Egyptian cirrhotic patients with diabetes mellitus and diabetic neuropathy. Adult patients aged >18 years with confirmed liver cirrhosis, concomitant diabetes mellitus and diabetic neuropathy were eligible for inclusion. Patients were experienced acute episodes of disease associated with deterioration of hepatic function within 2 months prior to screening, and received concomitant medications known to strongly interact with the study drugs were excluded. In part 1: Sitagliptin dosing was determined based on Simcyp -generated predictions and clinical assessment. 100mg,100 mg, 50 mg, and 50 mg received by control, CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. In part 2: Duloxetine dosing was determined based on Simcyp-generated predictions and clinical assessment. 60 mg ,30 mg received by control, and CP-A cirrhotic patients orally once daily, respectively. Clinical evaluation included glycemic parameters(HbA1C,fasting blood glucose,2-hr post prandial glucose level) and pain reduction. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT],and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]),and CBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Parallel-assignment interventional study to compare dose-adjusted sitagliptin and duloxetine across Child-Pugh classes with standard-dose diabetic controls."
| Arm | Type | Receives |
|---|---|---|
| Control -Standard Dose Sitagliptin | Active comparator | Drug: Sitagliptin (JANUVIA®)Sitagliptin (100 mg) |
| Child-Pugh A Sitagliptin | Experimental | Drug: Sitagliptin (Januvia)CP-A: Sitagliptin 100 mg |
| Child-Pugh B Sitagliptin | Experimental | Drug: Sitagliptin (JANUVIA®)CP-B: Sitagliptin 50 mg |
| Child-Pugh C Sitagliptin | Experimental | Drug: Sitagliptin (JANUVIA®)CP-C :Sitagliptin 50 mg |
| Control -Standard Dose Duloxetine | Active comparator | Drug: Duloxetine (60 mg) once dailyDuloxetine (60 mg) |
| Child-Pugh A | Experimental | Drug: Duloxetine 30mg once dailyCP-A: 30 mg Duloxetine |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of cirrhosis.
- Diagnosed with diabetes mellitus.
- Presence of diabetic neuropathy.
- Age of patients > 18 years.
Key exclusion criteria (2 listed)
- Patients with kidney disorder or dialysis
- Pregnancy
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 (Januvia)Diabetic patients with Child-Pugh class A hepatic cirrhosis receiving 100 mg model -informed adjusted dose of sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. | Drug | Child-Pugh A Sitagliptin |
| Sitagliptin (JANUVIA®)Diabetic patients with Child-Pugh class C hepatic cirrhosis receiving 50 mg model -informed adjusted dose of sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. | Drug | Child-Pugh C Sitagliptin |
| Sitagliptin (JANUVIA®)Diabetic patients with Child-Pugh class B hepatic cirrhosis receiving 50 mg model -informed adjusted dose of sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. | Drug | Child-Pugh B Sitagliptin |
| Sitagliptin (JANUVIA®)Diabetic patients without hepatic cirrhosis receiving the standard recommended dose of 100 mg sitagliptin. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. | Drug | Control -Standard Dose Sitagliptin |
| Duloxetine (60 mg) once dailyDiabetic patients without hepatic cirrhosis receiving the standard recommended dose of 60 mg Duloxetine. Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor, It has since received approval for a variety of indications including the treatment of neuropathic pain. | Drug | Control -Standard Dose Duloxetine |
| Duloxetine 30mg once dailyDiabetic patients with peripheral diabetic neuropathy and Child-Pugh class A hepatic cirrhosis receiving 30 mg model -informed adjusted dose of duloxetine. Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor, It has since received approval for a variety of indications including the treatment of neuropathic pain. | Drug | Child-Pugh A |
Primary outcome
Management of diabetes mellitus and diabetic neuropathy
Time frame: 3 months
by measuring glycemic parameters ( fasting blood glucose level,2-hr postprandial glucose level) (mg/dL).
1 secondary outcome
Adverse Effects Monitoring
Time frame: 3 months
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 27 Feb 2026.
- Results publication: PubMed 26191473Asakawa M, Mitsui H, Akihisa M, Sekine T, Niitsu Y, Kobayashi A, Miyake A, Hashimoto N, Kawamura M, Ogawa Y. Efficacy and safety of sitagliptin for the treatment of diabetes mellitus complicated by chronic liver injury. Springerplus. 2015 Jul 15;4:346. doi: 10.1186/s40064-015-1135-z. eCollection 2015.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Noha Mahmoud ELkhodary, PhD study director
Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
Aya Emad Fouda, MSc in Clinical Pharmacy principal investigator
Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
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 Sitagliptin (Januvia), Sitagliptin (JANUVIA®) and Duloxetine (60 mg) once daily in people with Liver Cirrhosis With Diabetes, run by Kafrelsheikh 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 4 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 27 Feb 2026. 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.
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?
Management of diabetes mellitus and diabetic neuropathy (time frame: 3 months). 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 NCT07439536, which also lists 1 linked publication.
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 27 Feb 2026.