Type 2 DiabetesPhase 2SPPSNCT01342042
The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
A Phase 2 study testing rExenatide-4 in people with Type 2 Diabetes, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial. Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- rExenatide-4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ~ 75 years with T2DM in China;
- HbA1c of 7% to 13%;
- negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months.
Who cannot join
- HBsAg, HCV, HIV and syphilis test was positive;
- any time FBG <6.1 or> 14.0 mmol / L in the morning;
- Renal function: eGFR <60 mL / min ;
- TG> 5mmol / L;
- Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases;
- Ischemic heart disease, heart failure, stroke or peripheral vascular disease;
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- Pregnancy and breast-feeding women;
- Patients requiring insulin treatment;
- Have medical history of hypoglycemia;
- Have a clear history of allergic patients;
- Patients addicted to alcohol and tobacco.
Trial locations and contacts
1 site in 1 country.
Cui Yi Min, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 010
Cui Yi Min, MD, 86-10-88325988
Cui Yi Min, MD
About this study
Official title: The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM
This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial.
Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d~ 8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.
- Conditions
- Type 2 Diabetes
- Being tested
- rExenatide-4
- Keywords
- diabetes, rRE-4, exenatide, metformin, CSPC ZhongQi
- 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.
rExenatide-4Biological
This protein of 39 amino acids has been isolated from the venom of the lizard Heloderma suspectum (Gila monster) (Eng et al, 1992). A mammalian homolog does not seem to exist (Pohl and Wank, 1998). Exendin-4 shares 53 % identity at the amino acid level with that of the mammalian hormone GLP-1 [glucagon-like peptide-1] (Chen and Drucker, 1997). Exendin-4 is encoded within a prohormone that is distinct from the prohormone encoding glucagon. Using transgenic mice expressing exendin-4, Adatia et al (2002) have shown that mammalian cells process the lizard prohormone in endocrine and nonendocrine cell types in vitro and in murine tissues in vivo.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Not described Receives: Biological: rExenatide-4 |
| exenatide-4 | Active comparator | Not described Receives: Biological: rExenatide-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare treatment arms in terms of change from baseline to endpoint in HbA1c
To observe and compare the differences in pharmacokinetic parameters with the reatment of rE-4, adding metformin to rE-4 and exenatide, To compare treatment arms in terms of change from baseline to endpoint in HbA1c
Measured: 12 Weeks
Secondary outcomes (4)
To compare treatment arms in terms of change from baseline to endpoint in GA
Measured: 12 Weeks
To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose
Measured: 12 Weeks
To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour
Measured: 12 weeks
To compare treatment arms in terms of change from baseline to endpoint in body weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cui Yi min, MD, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342042
- Sponsor's protocol ID
- CSPC/PRO-rE4/IIa-04
- Acronym
- SPPS
- Status last verified
- Apr 2011
- First submitted
- 23 Apr 2011
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Y, Xu B, Zhu L, Lou K, Chen Y, Zhao X, Wang Q, Xu L, Guo X, Ji L, Cui Y, Fang Y. Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus. Clin Drug Investig. 2017 Dec;37(12):1107-1115. doi: 10.1007/s40261-017-0569-1.
PubMed 28932995
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM
- ClinicalTrials.gov ID
- NCT01342042
- Acronym / sponsor ID
- SPPS / CSPC/PRO-rE4/IIa-04
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, rRE-4, exenatide, metformin, CSPC ZhongQi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital, Peking University First Hospital
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 26 Apr 2011 (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.
This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial.
Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d~ 8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Biological: rExenatide-4 |
| exenatide-4 | Active comparator | Biological: rExenatide-4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 ~ 75 years with T2DM in China;
- HbA1c of 7% to 13%;
- negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months.
Key exclusion criteria (11 listed)
- HBsAg, HCV, HIV and syphilis test was positive;
- any time FBG <6.1 or> 14.0 mmol / L in the morning;
- Renal function: eGFR <60 mL / min ;
- TG> 5mmol / L;
- Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases;
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 |
|---|---|---|
| rExenatide-4This protein of 39 amino acids has been isolated from the venom of the lizard Heloderma suspectum (Gila monster) (Eng et al, 1992). A mammalian homolog does not seem to exist (Pohl and Wank, 1998). Exendin-4 shares 53 % identity at the amino acid level with that of the mammalian hormone GLP-1 [glucagon-like peptide-1] (Chen and Drucker, 1997). Exendin-4 is encoded within a prohormone that is distinct from the prohormone encoding glucagon. Using transgenic mice expressing exendin-4, Adatia et al (2002) have shown that mammalian cells process the lizard prohormone in endocrine and nonendocrine cell types in vitro and in murine tissues in vivo. | Biological | Metformin, exenatide-4 |
Primary outcome
To compare treatment arms in terms of change from baseline to endpoint in HbA1c
Time frame: 12 Weeks
To observe and compare the differences in pharmacokinetic parameters with the reatment of rE-4, adding metformin to rE-4 and exenatide, To compare treatment arms in terms of change from baseline to endpoint in HbA1c
4 secondary outcomes
To compare treatment arms in terms of change from baseline to endpoint in GA
Time frame: 12 Weeks
To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose
Time frame: 12 Weeks
To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour
Time frame: 12 weeks
To compare treatment arms in terms of change from baseline to endpoint in body weight
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
- Derived from this study: PubMed 28932995Wang Y, Xu B, Zhu L, Lou K, Chen Y, Zhao X, Wang Q, Xu L, Guo X, Ji L, Cui Y, Fang Y. Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus. Clin Drug Investig. 2017 Dec;37(12):1107-1115. doi: 10.1007/s40261-017-0569-1.
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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.
Cui Yi Min, MD contact
Cui Yi min, MD study director
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rExenatide-4 in people with Type 2 Diabetes, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 11 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 26 Apr 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cui Yi Min, MD (86-10-88325988), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare treatment arms in terms of change from baseline to endpoint in HbA1c (time frame: 12 Weeks). 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 NCT01342042, 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 26 Apr 2011.