Type 2 DiabetesPhase 4NCT02291666
Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects
A Phase 4 study testing CRCHUM-MT cocktail in people with Type 2 Diabetes, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CRCHUM-MT cocktail
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jul 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be ≥18 years old
- Body weight index ≤35,
- Non-smokers (>3 months)
- Patients with type 2 diabetes and good glycemic control (A1C<7) or poor glycemic control (A1C>7.0) and healthy non-diabetic subjects will be eligible.
Who cannot join
- Subjects with estimated glomerular filtration (MDRD) <50mL/min/1.73m2
- ALT and AST 3 times above the upper limit of normal
- Organ transplant recipient, inflammatory illnesses (i.e., polyarthritis, severe cirrhosis, infectious diseases, heart failure, HIV, hepatitis)
- Previous history of or an active cancer (except non-melanoma skin cancer)
- Uncontrolled thyroid functions
- Pregnant
Show all 10Show fewer
- History of drug or alcohol abuse
- Subjects with a history of or current inflammatory bowel diseases including ulcerous colitis and Crohn's disease, and bariatric surgery
- Drugs known to modulate CYP450 activities, subject taking one of the following therapies will be excluded: antibiotics, antivirals, anticancers, CYP450 inducers (carbamazepine, phenobarbital, phenytoin, rifampin, St-John's wort), CYP450 inhibitors (amiodarone, fluvoxamine, fluoxetine, verapamil), immunosuppressors, warfarin, INFs, antibodies or grapefruit juice (<2-4 weeks) , CYP450 drugs with strong affinity for the selected isoform and with a long half-life, CYP450 mechanism-based inhibitors or an investigational drug
- Intolerance or hypersensitivity to probe drugs in the CRCHUM-MT cocktail or chlorzoxazone/acetaminophen
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X0A9
About this study
Official title: Effects of Type 2 Diabetes on CYP450s Activities; Intersubject Variability in Drug Metabolism.
Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. In our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and macro-vascular complications and inadequately controlled T2D due to high intersubject variability in drug disposition and action.
Characterization of the effects of T2D on drug metabolism capacity will be performed using a cocktail of CYP450 probe drugs.
Read more
CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2), bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1). Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated and compared between three groups of subjects. Other co-variables to be studied include T2D biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and inflammatory markers.
Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the activity of major CYP450s. Moreover, this project will indicate to us whether glycemic control should be considered as a covariate of intersubject variability in drug metabolism capacity.
Read the detailed description
Patients with type 2 diabetes (T2D) require various therapeutic approaches (diet, exercise and drugs) to ensure glycaemic control while minimizing the risk of hypoglycaemia. T2D is also associated with vascular morbidities necessitating multiple drugs to prevent cardiovascular complications. Clinical practice reveals that T2D patients show highly variable responses to different drugs. Variable drug dosages and effects are observed for drugs such as clopidogrel, warfarin, cyclosporine and tacrolimus, as well as for anti-hypertensive, cholesterol lowering and antidiabetic drugs. These observations strongly suggest that T2D modulates factors regulating drug disposition and/or drug effects.
The hypothesis underlying this proposal is: T2D and its abnormalities alter the expression and activities of CYP450s involved in the disposition of drugs used to treat T2D and associated comorbidities.
The overall objective of this project is to investigate the effects of T2D on the activity of several CYP450 isozymes. Primary objective: To compare CYP450 activities between diabetic and non-diabetic subjects following a single oral administration of a cocktail of CYP450 probe drugs. The secondary objective: To evaluate and compare CYP450 activities according to the glycemic control (T2D patients with good glycemic control; T2D patients with poor glycemic control; and non-diabetic healthy subjects).
Study design; Patients (n=126) will be recruited to constitute 3 groups: Group I, 42 confirmed T2D with HbA1c ≤7.0; Group II, 42 patients with poor glycemic control HbA1c>7.0, and Group III, 42 sexed-matched non-T2D healthy subjects. This design will allow us to compare CYP450 activities between T2D patients with good glycemic control, T2D patients with poor glycemic control, and non-diabetic healthy subjects. Participants will be ≥18 years old, with a body weight index ≤35, and be non-smokers (>3 months). Subjects will be recruited at the CHUM outpatient clinic. The T2D diagnosis will be established according to the Canadian clinical guidelines. After an overnight fast, participants will be admitted to the CRCHUM's Clinical Research Unit (they will be not hospitalized). Subjects will receive the CRCHUM-MT cocktail; 100mg caffeine, 100mg bupropion, 250mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan and 2mg midazolam to phenotype for CYP1A2, 2B6, 2C9, 2C19, 2B6, 2D6 and 3A4/5, respectively. Serial blood samples will be drawn and urine collected over 8 hours following drug administration. At the end of study day, subjects will be discharged from the CRCHUM's Clinical Research Unit and an oral 250mg dose of chlorzoxazone (CYP2E1) will be given and urine collected overnight for 12 hours.
A blood sample will be taken for pharmacogenetic analysis for relevant drug metabolizing enzymes. Additional blood samples will be collected just before the administration of the cocktail to measure insulin, glycaemia and HbA1c levels, biomarkers and inflammatory markers.
The subjects will be instructed not to take any medication, caffeine or theobromine containing products on the morning of study day. Their regular medication will be administered 4 hours after the administration of the cocktail if indicated. The subjects in whom our probe marker drugs are used daily will still be enrolled as metabolic ratios and will be determined to establish CYP450 activities.
Pharmacokinetic parameters such as oral clearance, metabolic clearance and renal clearance will be determined by noncompartmental analysis. Metabolic ratios will be calculated and compared between three groups of subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- CRCHUM-MT cocktail
- Keywords
- Cytochromes p450, drug metabolism, pharmacokinetics, diabetes, probe markers
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRCHUM-MT cocktailDrug
Also called omeprazole, Losec, caffeine, Wake-up
| Study group | Role | What they receive |
|---|---|---|
| T2D patients with A1C ≤7.0 | Experimental | CRCHUM-MT cocktail; a single oral dose of the CRCHUM-MT cocktail will be administered; 100mg caffeine, 75mg bupropion, 150mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan, 2mg midazolam and at night, one oral 250mg dose of chlorzoxazone will be taken separately. Receives: Drug: CRCHUM-MT cocktail |
| T2D patients with A1C>7.0 | Experimental | CRCHUM-MT cocktail; a single oral dose of the CRCHUM-MT cocktail will be administered; 100mg caffeine, 75mg bupropion, 150mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan, 2mg midazolam and at night, one oral 250mg dose of chlorzoxazone will be taken separately. Receives: Drug: CRCHUM-MT cocktail |
| Non T2D subjects | Active comparator | CRCHUM-MT cocktail; a single oral dose of the CRCHUM-MT cocktail will be administered; 100mg caffeine, 75mg bupropion, 150mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan, 2mg midazolam and at night, one oral 250mg dose of chlorzoxazone will be taken separately. Receives: Drug: CRCHUM-MT cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic ratio
The metabolite/probe-drug (parent compound) ratio will be used as a metabolic index of CYP activity.
Measured: 12 hours
Secondary outcomes (2)
Oral clearance
CLo will be determined by noncompartmental analysis
Measured: 12 hours
Renal clearance
CLr will be determined by noncompartmental analysis (Ae0-t of compound/AUC0-t compound)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Veronique Michaud, BPharm, PhD, Principal investigator, Centre de recherche du Centre Hospitalier de l'université de Montréal (CHUM)Jean-Louis Chiasson, MD, Study director, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291666
- Sponsor's protocol ID
- CE 14.066
- Status last verified
- Jul 2017
- First submitted
- 30 Oct 2014
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gravel S, Chiasson JL, Turgeon J, Grangeon A, Michaud V. Modulation of CYP450 Activities in Patients With Type 2 Diabetes. Clin Pharmacol Ther. 2019 Dec;106(6):1280-1289. doi: 10.1002/cpt.1496. Epub 2019 Jul 9.
PubMed 31099895Gravel S, Chiasson JL, Dallaire S, Turgeon J, Michaud V. Evaluating the impact of type 2 diabetes mellitus on CYP450 metabolic activities: protocol for a case-control pharmacokinetic study. BMJ Open. 2018 Feb 8;8(2):e020922. doi: 10.1136/bmjopen-2017-020922.
PubMed 29439084
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Type 2 Diabetes on CYP450s Activities; Intersubject Variability in Drug Metabolism.
- ClinicalTrials.gov ID
- NCT02291666
- Acronym / sponsor ID
- CE 14.066
- Conditions
- Type 2 Diabetes
- Keywords
- Cytochromes p450, drug metabolism, pharmacokinetics, diabetes, probe markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 14 Nov 2014 (estimated)
- 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.
Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. In our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and macro-vascular complications and inadequately controlled T2D due to high intersubject variability in drug disposition and action.
Characterization of the effects of T2D on drug metabolism capacity will be performed using a cocktail of CYP450 probe drugs.
CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2), bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1). Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated and compared between three groups of subjects. Other co-variables to be studied include T2D biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and inflammatory markers.
Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the activity of major CYP450s. Moreover, this project will indicate to us whether glycemic control should be considered as a covariate of intersubject variability in drug metabolism capacity.
Detailed description
Patients with type 2 diabetes (T2D) require various therapeutic approaches (diet, exercise and drugs) to ensure glycaemic control while minimizing the risk of hypoglycaemia. T2D is also associated with vascular morbidities necessitating multiple drugs to prevent cardiovascular complications. Clinical practice reveals that T2D patients show highly variable responses to different drugs. Variable drug dosages and effects are observed for drugs such as clopidogrel, warfarin, cyclosporine and tacrolimus, as well as for anti-hypertensive, cholesterol lowering and antidiabetic drugs. These observations strongly suggest that T2D modulates factors regulating drug disposition and/or drug effects.
The hypothesis underlying this proposal is: T2D and its abnormalities alter the expression and activities of CYP450s involved in the disposition of drugs used to treat T2D and associated comorbidities.
The overall objective of this project is to investigate the effects of T2D on the activity of several CYP450 isozymes. Primary objective: To compare CYP450 activities between diabetic and non-diabetic subjects following a single oral administration of a cocktail of CYP450 probe drugs. The secondary objective: To evaluate and compare CYP450 activities according to the glycemic control (T2D patients with good glycemic control; T2D patients with poor glycemic control; and non-diabetic healthy subjects).
Study design; Patients (n=126) will be recruited to constitute 3 groups: Group I, 42 confirmed T2D with HbA1c ≤7.0; Group II, 42 patients with poor glycemic control HbA1c>7.0, and Group III, 42 sexed-matched non-T2D healthy subjects. This design will allow us to compare CYP450 activities between T2D patients with good glycemic control, T2D patients with poor glycemic control, and non-diabetic healthy subjects. Participants will be ≥18 years old, with a body weight index ≤35, and be non-smokers (>3 months). Subjects will be recruited at the CHUM outpatient clinic. The T2D diagnosis will be established according to the Canadian clinical guidelines. After an overnight fast, participants will be admitted to the CRCHUM's Clinical Research Unit (they will be not hospitalized). Subjects will receive the CRCHUM-MT cocktail; 100mg caffeine, 100mg bupropion, 250mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan and 2mg midazolam to phenotype for CYP1A2, 2B6, 2C9, 2C19, 2B6, 2D6 and 3A4/5, respectively. Serial blood samples will be drawn and urine collected over 8 hours following drug administration. At the end of study day, subjects will be discharged from the CRCHUM's Clinical Research Unit and an oral 250mg dose of chlorzoxazone (CYP2E1) will be given and urine collected overnight for 12 hours.
A blood sample will be taken for pharmacogenetic analysis for relevant drug metabolizing enzymes. Additional blood samples will be collected just before the administration of the cocktail to measure insulin, glycaemia and HbA1c levels, biomarkers and inflammatory markers.
The subjects will be instructed not to take any medication, caffeine or theobromine containing products on the morning of study day. Their regular medication will be administered 4 hours after the administration of the cocktail if indicated. The subjects in whom our probe marker drugs are used daily will still be enrolled as metabolic ratios and will be determined to establish CYP450 activities.
Pharmacokinetic parameters such as oral clearance, metabolic clearance and renal clearance will be determined by noncompartmental analysis. Metabolic ratios will be calculated and compared between three groups of subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2D patients with A1C ≤7.0 | Experimental | Drug: CRCHUM-MT cocktailCRCHUM-MT cocktail; a single oral dose of the CRCHUM-MT cocktail will be administered; 100mg caffeine, 75mg bupropion, 150mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan, 2mg midazolam and at night, one oral 250mg dose of chlorzoxazone will be taken separately. |
| T2D patients with A1C>7.0 | Experimental | Drug: CRCHUM-MT cocktailCRCHUM-MT cocktail; a single oral dose of the CRCHUM-MT cocktail will be administered; 100mg caffeine, 75mg bupropion, 150mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan, 2mg midazolam and at night, one oral 250mg dose of chlorzoxazone will be taken separately. |
| Non T2D subjects | Active comparator | Drug: CRCHUM-MT cocktailCRCHUM-MT cocktail; a single oral dose of the CRCHUM-MT cocktail will be administered; 100mg caffeine, 75mg bupropion, 150mg tolbutamide, 20mg omeprazole, 30mg dextromethorphan, 2mg midazolam and at night, one oral 250mg dose of chlorzoxazone will be taken separately. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be ≥18 years old
- Body weight index ≤35,
- Non-smokers (>3 months)
- Patients with type 2 diabetes and good glycemic control (A1C<7) or poor glycemic control (A1C>7.0) and healthy non-diabetic subjects will be eligible.
Key exclusion criteria (10 listed)
- Subjects with estimated glomerular filtration (MDRD) <50mL/min/1.73m2
- ALT and AST 3 times above the upper limit of normal
- Organ transplant recipient, inflammatory illnesses (i.e., polyarthritis, severe cirrhosis, infectious diseases, heart failure, HIV, hepatitis)
- Previous history of or an active cancer (except non-melanoma skin cancer)
- Uncontrolled thyroid functions
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 |
|---|---|---|
| CRCHUM-MT cocktailAlso: omeprazole, Losec, caffeine, Wake-up | Drug | Non T2D subjects, T2D patients with A1C ≤7.0, T2D patients with A1C>7.0 |
Primary outcome
Metabolic ratio
Time frame: 12 hours
The metabolite/probe-drug (parent compound) ratio will be used as a metabolic index of CYP activity.
2 secondary outcomes
Oral clearance
Time frame: 12 hours
Renal clearance
Time frame: 12 hours
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 23 Jul 2019.
- Derived from this study: PubMed 31099895Gravel S, Chiasson JL, Turgeon J, Grangeon A, Michaud V. Modulation of CYP450 Activities in Patients With Type 2 Diabetes. Clin Pharmacol Ther. 2019 Dec;106(6):1280-1289. doi: 10.1002/cpt.1496. Epub 2019 Jul 9.
- Derived from this study: PubMed 29439084Gravel S, Chiasson JL, Dallaire S, Turgeon J, Michaud V. Evaluating the impact of type 2 diabetes mellitus on CYP450 metabolic activities: protocol for a case-control pharmacokinetic study. BMJ Open. 2018 Feb 8;8(2):e020922. doi: 10.1136/bmjopen-2017-020922.
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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.
Veronique Michaud, BPharm, PhD principal investigator
Centre de recherche du Centre Hospitalier de l'université de Montréal (CHUM)
Jean-Louis Chiasson, MD study director
Centre hospitalier de l'Université de Montréal (CHUM)
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 CRCHUM-MT cocktail in people with Type 2 Diabetes, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 10 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 23 Jul 2019. 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 Canada. 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?
Metabolic ratio (time frame: 12 hours). 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 NCT02291666, which also lists 2 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 23 Jul 2019.