Diabetes Mellitus, Type 2NCT04170790
Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
A study testing Saxagliptin 5mg and Sildenafil 50 mg in people with Diabetes Mellitus, Type 2 and Erectile Dysfunction With Diabetes Mellitus, run by Ain Shams University.
Trial summary
Patients with diabetes are three times more likely to develop erectile dysfunction (ED), and longer duration of diabetes is strongly associated with ED. The possibility of pharmacokinetic interactions may occur as the two drugs are metabolized by hepatic CYP3A4 and their co administration may affect their plasma… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Erectile Dysfunction With Diabetes Mellitus, Drug Interaction
- What is being tested?
- Saxagliptin 5mg and Sildenafil 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 30 Jan 2020
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years.
- Ideal weight within the normal range according to accepted life tables.
- Non-contributory history and normal physiological examination.
- Laboratory data within normal limits.
- Performance and compliance.
- The subjects should be without known history of alcohol or drug abuse problems and should preferably be non-smokers.
- The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests (hematology, clinical chemistry, urinalysis serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).
Who cannot join
- A known hypersensitivity to the drug.
- Gastrointestinal diseases.
- Auto immune diseases.
- Renal diseases or dysfunction.
- Cardiovascular disease of any type.
- Pancreatic disease including diabetes.
Show all 17Show fewer
- Hepatic disease.
- Hematological, osteopathic, or pulmonary disease.
- History of alcoholism or drug abuse.
- Serious Psychological illness.
- Positive HIV-I.
- Smoking (if including they should be identified).
- Abnormal (out of range) laboratory values.
- Subject who have taken any medication (Rx or OTC) less than two weeks of the trials starting date.
- Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Treatment with any known enzyme-inducing / inhibiting agents within 30 days prior to the start of the study and throughout the study.
Trial locations and contacts
No sites are listed yet.
About this study
Patients with diabetes are three times more likely to develop erectile dysfunction (ED), and longer duration of diabetes is strongly associated with ED. The possibility of pharmacokinetic interactions may occur as the two drugs are metabolized by hepatic CYP3A4 and their co administration may affect their plasma concentrations. the aim of work is to investigate the effect of sildenafil a CYP3A4 substrate and inhibitor on the pharmacokinetics and safety of Saxagliptin, a CYP3A4 substrate Subjects and Methods: Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin.
- Being tested
- Saxagliptin 5mg, Sildenafil 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.
Saxagliptin 5mgDrug
Also called Onglyza
Saxagliptin 5mg oral tablet
Sildenafil 50 mgDrug
Also called Viagra
Sildenafil 50 mg Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Day 1: Sildenafil 50 mg single dose Day 2-Day 8: Washout period Day 9-12: Saxagliptin 5 mg Once/day Day 13: Sildenafil 50 mg+ Saxagliptin 5 mg Receives: Drug: Saxagliptin 5mg; Drug: Sildenafil 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Plasma Concentration
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
(AUC0→∞)
Area Under Curve Infinity
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
(AUC0→t)
Area Under the Curve
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
tmax;
Time to reach Maximum concentration
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
T½
Drug half Life
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Ke
Elimination Rate
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
ka
Absorption Rate
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Blood Pressure
changes in Systolic and Diastolic Blood Pressure from normal range
Measured: measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling
Heart Rate
Changes in heart rate from normal range
Measured: measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jan 2020 (estimated)
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Health services research
- Intervention model
- Sequential
- Model description
- Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Yousri Mansour, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170790
- Sponsor's protocol ID
- 57
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mansour RY, ElBorolossy R, Shaheen SM, Sabri NA. Evaluation of drug interactions of saxagliptin with sildenafil in healthy volunteers. Eur J Clin Pharmacol. 2022 Dec;78(12):1935-1944. doi: 10.1007/s00228-022-03397-w. Epub 2022 Oct 10.
PubMed 36214883
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04170790
- Acronym / sponsor ID
- 57
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 20 Nov 2019 (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.
Patients with diabetes are three times more likely to develop erectile dysfunction (ED), and longer duration of diabetes is strongly associated with ED. The possibility of pharmacokinetic interactions may occur as the two drugs are metabolized by hepatic CYP3A4 and their co administration may affect their plasma concentrations. the aim of work is to investigate the effect of sildenafil a CYP3A4 substrate and inhibitor on the pharmacokinetics and safety of Saxagliptin, a CYP3A4 substrate Subjects and Methods: Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin.
Study design
- Primary purpose
- Health services research
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Drug: Saxagliptin 5mg, Drug: Sildenafil 50 mgDay 1: Sildenafil 50 mg single dose Day 2-Day 8: Washout period Day 9-12: Saxagliptin 5 mg Once/day Day 13: Sildenafil 50 mg+ Saxagliptin 5 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-45 years.
- Ideal weight within the normal range according to accepted life tables.
- Non-contributory history and normal physiological examination.
- Laboratory data within normal limits.
- Performance and compliance.
Key exclusion criteria (17 listed)
- A known hypersensitivity to the drug.
- Gastrointestinal diseases.
- Auto immune diseases.
- Renal diseases or dysfunction.
- Cardiovascular disease of any type.
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 |
|---|---|---|
| Saxagliptin 5mgAlso: OnglyzaSaxagliptin 5mg oral tablet | Drug | Healthy volunteer |
| Sildenafil 50 mgAlso: ViagraSildenafil 50 mg Oral Tablet | Drug | Healthy volunteer |
Primary outcome
Cmax
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Maximum Plasma Concentration
(AUC0→∞)
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Area Under Curve Infinity
(AUC0→t)
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Area Under the Curve
tmax;
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Time to reach Maximum concentration
T½
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Drug half Life
Ke
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Elimination Rate
ka
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.
Absorption Rate
Blood Pressure
Time frame: measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling
changes in Systolic and Diastolic Blood Pressure from normal range
Heart Rate
Time frame: measured before dosing and at 2, 4, 6, 8, and 10 hours after drug administration on each day of blood sampling
Changes in heart rate from normal range
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Derived from this study: PubMed 36214883Mansour RY, ElBorolossy R, Shaheen SM, Sabri NA. Evaluation of drug interactions of saxagliptin with sildenafil in healthy volunteers. Eur J Clin Pharmacol. 2022 Dec;78(12):1935-1944. doi: 10.1007/s00228-022-03397-w. Epub 2022 Oct 10.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Saxagliptin 5mg and Sildenafil 50 mg in people with Diabetes Mellitus, Type 2 and Erectile Dysfunction With Diabetes Mellitus, run by Ain Shams University.
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania Y Mansour, MD (0201000350066, rania.mansour@mehy-eg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, and 24 hours post-dose.). The study lists 9 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 NCT04170790, 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 20 Nov 2019.