Type 2 DiabetesPhase 1NCT01976858
A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
A Phase 1 study testing PEX168 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG). This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- PEX168
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.
- HbA1C 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/L after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone).
- unused insulin within 3 months prior to the enrollment.
- Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.
- Normol liver, kidney, heart function.
- Willing to use physical means of contraception during the trial stage.
- voluntarily to participate in the study.
Who cannot join
- 1 diabetes.
- used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.
- have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history
- There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.
- with severe diabetes complications ( renal , retinal , nerve , vascular disease).
- has acute and chronic pancreatitis history ;
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- heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ;
- There is a history of hypertension and blood pressure is not well controlled : SBP> 160mmHg and / or DBP> 95mmHg persons ;
- severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ;
- There are obvious blood system diseases ;
- There are other endocrine system diseases , such as hyperthyroidism , etc. ;
- with severe trauma or surgery , severe infection ;
- have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ;
- used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ;
- within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ;
- were receiving steroids or are receiving cancer treatment ;
- has been prepared during pregnancy or pregnancy test in female patients ;
- hepatitis B HBeAg , hepatitis C antibody positive , HIV antibody positive , syphilis antibody positive .
- skin test positive of PEX168;
- The researchers considered any factors that the subject should not participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Multicenter, Randomized Study Evaluating the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 8 Weeks Injection of Polyethylene Glycol Loxenatide
Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG).
This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.
- Conditions
- Type 2 Diabetes
- Being tested
- PEX168
- Keywords
- PEX168, diabetes, phase I
- 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.
PEX168Drug
Also called Polyethylene Glycol Loxenatide
A injection administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| PEX168 50 microgram | Experimental | PEX168 50 microgram qw sc. and the medication continued for 8 weeks Receives: Drug: PEX168 |
| PEX168 100 microgram | Experimental | PEX168 100 microgram qw sc. and the medication continued for 8 weeks Receives: Drug: PEX168 |
| PEX168 200 microgram | Experimental | PEX168 200 microgram qw sc. and the medication continued for 8 weeks Receives: Drug: PEX168 |
| PEX168 300 microgram | Experimental | PEX168 300 microgram qw sc. and the medication continued for 8 weeks Receives: Drug: PEX168 |
| Placebo | Placebo comparator | Placebo qw sc. and the medication continued for 12 weeks Receives: Drug: PEX168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine serum concentrations of PEX168
Measured: 8 weeks
Secondary outcomes (1)
To determin HbA1c levels of PEX168
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Sponsor
- Investigators
- Jinkui Yang, Ph.D, M.D, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976858
- Sponsor's protocol ID
- PEX168-I-03
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multicenter, Randomized Study Evaluating the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 8 Weeks Injection of Polyethylene Glycol Loxenatide
- ClinicalTrials.gov ID
- NCT01976858
- Acronym / sponsor ID
- PEX168-I-03
- Conditions
- Type 2 Diabetes
- Keywords
- PEX168, diabetes, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tongren Hospital
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Nov 2013 (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.
Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG).
This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PEX168 50 microgram | Experimental | Drug: PEX168PEX168 50 microgram qw sc. and the medication continued for 8 weeks |
| PEX168 100 microgram | Experimental | Drug: PEX168PEX168 100 microgram qw sc. and the medication continued for 8 weeks |
| PEX168 200 microgram | Experimental | Drug: PEX168PEX168 200 microgram qw sc. and the medication continued for 8 weeks |
| PEX168 300 microgram | Experimental | Drug: PEX168PEX168 300 microgram qw sc. and the medication continued for 8 weeks |
| Placebo | Placebo comparator | Drug: PEX168Placebo qw sc. and the medication continued for 12 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.
- HbA1C 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/L after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone).
- unused insulin within 3 months prior to the enrollment.
- Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.
- Normol liver, kidney, heart function.
Key exclusion criteria (20 listed)
- 1 diabetes.
- used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.
- have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history
- There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.
- with severe diabetes complications ( renal , retinal , nerve , vascular disease).
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 |
|---|---|---|
| PEX168Also: Polyethylene Glycol LoxenatideA injection administered subcutaneously | Drug | PEX168 100 microgram, PEX168 200 microgram, PEX168 300 microgram, PEX168 50 microgram, Placebo |
Primary outcome
To determine serum concentrations of PEX168
Time frame: 8 weeks
1 secondary outcome
To determin HbA1c levels of PEX168
Time frame: 8 weeks
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 6 Nov 2013.
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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.
Jinkui Yang, Ph.D, M.D principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEX168 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine 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 7 inclusion and 20 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 6 Nov 2013. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine serum concentrations of PEX168 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
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 6 Nov 2013.