GenotypeNCT01082796
Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects
A study testing Glipizide in people with Genotype and Pharmacokinetic, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Genotype, Pharmacokinetic
- What is being tested?
- Glipizide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Jan 2010
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- healthy
- nonsmokers
Who cannot join
- BMI > 24 or BMI < 19
- had any family history of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
China1 site
Departmant of Clinical Pharmacology, the First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000
About this study
Official title: Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects
Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Little information has been presented for the relationship between CYP2C19 genetic polymorphism and glipizide, since recently the investigators reported that there existed a tendency. In this study the investigators found that CYP2C19 polymorphism significantly influenced the pharmacokinetics of glipizide.
Read the detailed description
Blood samples were obtained from 127 unrelated healthy male Chinese subjects in Gansu Province. After genotyping, 14 subjects (age, 19-26; weight, 59.5-70.0 kg) were enrolled in the study. They were divided into two groups, EMs homo and PMs group. There were no significant differences in age or body weight seen in the two groups.
Each subject received 5 mg glipizide extended release tablet once daily for 7 days. For the first 6 days, glipizide was administered just after a standard breakfast. On day 7, after an overnight fast, each subject received a glipizide extended released tablet (Glucotrol XL, Pfizer, USA) with 100 mL water. Standard meals were given in 4 h and 10 h after dosing. Venous blood samples were collected immediately before and at 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 36, and 48 h after dosing. Blood samples, collected in EDTA tubes, were centrifuged (2500 g) immediately for 10 min and plasma samples separated were stored at -80ºC until assay.
For safety, blood glucose levels were determined directly by use of a Glucose Meter (Accu-Chek, Roche, Germany) at 0, 2, 4, 6, 8, 10, 12, 14, 16, 20and 24 h after last dosing (on day 7).
- Conditions
- Genotype, Pharmacokinetic
- Being tested
- Glipizide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlipizideDrug
Also called Glucotrol XL®
Each subject received 5 mg glipizide extended release tablet once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| CYP2C19 EMs group | Other | cyp2c19*1/*1 carriers Receives: Drug: Glipizide |
| CYP2C19 PMs group | Other | cyp2c19*2/*2 or *2/*3 Receives: Drug: Glipizide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenotypeStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- LanZhou University
- Investigators
- Da F Zhong, PH.D, Study director, Shanghai Institute of Materia Medica, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082796
- Sponsor's protocol ID
- SIMM-DMPK-090903
- Status last verified
- Nov 2009
- First submitted
- 4 Mar 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01082796
- Acronym / sponsor ID
- SIMM-DMPK-090903
- Conditions
- Genotype, Pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- LanZhou University
- Study start
- Nov 2009
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Mar 2010 (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.
Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Little information has been presented for the relationship between CYP2C19 genetic polymorphism and glipizide, since recently the investigators reported that there existed a tendency. In this study the investigators found that CYP2C19 polymorphism significantly influenced the pharmacokinetics of glipizide.
Detailed description
Blood samples were obtained from 127 unrelated healthy male Chinese subjects in Gansu Province. After genotyping, 14 subjects (age, 19-26; weight, 59.5-70.0 kg) were enrolled in the study. They were divided into two groups, EMs homo and PMs group. There were no significant differences in age or body weight seen in the two groups.
Each subject received 5 mg glipizide extended release tablet once daily for 7 days. For the first 6 days, glipizide was administered just after a standard breakfast. On day 7, after an overnight fast, each subject received a glipizide extended released tablet (Glucotrol XL, Pfizer, USA) with 100 mL water. Standard meals were given in 4 h and 10 h after dosing. Venous blood samples were collected immediately before and at 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 36, and 48 h after dosing. Blood samples, collected in EDTA tubes, were centrifuged (2500 g) immediately for 10 min and plasma samples separated were stored at -80ºC until assay.
For safety, blood glucose levels were determined directly by use of a Glucose Meter (Accu-Chek, Roche, Germany) at 0, 2, 4, 6, 8, 10, 12, 14, 16, 20and 24 h after last dosing (on day 7).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYP2C19 EMs group | Other | Drug: Glipizidecyp2c19*1/*1 carriers |
| CYP2C19 PMs group | Other | Drug: Glipizidecyp2c19*2/*2 or *2/*3 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- healthy
- nonsmokers
Key exclusion criteria (2 listed)
- BMI > 24 or BMI < 19
- had any family history of diabetes mellitus
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 |
|---|---|---|
| GlipizideAlso: Glucotrol XL®Each subject received 5 mg glipizide extended release tablet once daily for 7 days. | Drug | CYP2C19 EMs group, CYP2C19 PMs group |
Primary outcome
Not reported in the source record.
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 9 Mar 2010.
- Our organizationLink provided by the sponsor.
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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.
Da F Zhong, PH.D study director
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glipizide in people with Genotype and Pharmacokinetic, run by Chinese Academy of Sciences at 1 site in China.
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 9 Mar 2010. 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 China. 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.
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 9 Mar 2010.