Type 2 DiabetesPhase 2NCT01965509
A PK/PD Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
A Phase 2 study of 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Oct 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been diagnosed with type 2 diabetes mellitus.
- Has been treated with a stable dose of metformin monotherapy ≥ 12 weeks before randomization, and metformin dose ≥ 1500 mg / day.
- Has HbA1c of 7.5% to 11.0%(local) at screening. And has HbA1c of 7.0% to 11.0%(Central) before randomization.
- Is 20 to 70 years old, inclusive.
- Has a body mass index (BMI) of 19 kg/m2 to 35 kg/m2, inclusive.
Who cannot join
- Skin test of PEX168 is positive.
- Is currently treated with any of the following excluded medications:
- GLP-1 or GLP-1 analogues prior to study start;
- Insulin within 6 months prior to study start;
- Growth hormone within 6 months prior to study start;
- Abuse of drug or alcohol within 6 months prior to study start;
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- Any other hypoglycemic drugs (including Chinese herbal medicine) except for metformin within 3 months prior to study start;
- Any clinical trials of drugs or medical instruments within 3 months prior to study start;
- Systemic corticosteroids by oral, parenteral, or intra-articular route
- Any drugs for weight loss or operations leading to weight instable within 2 months prior to study start;
- Any drugs that may interfere the evaluation of safety and efficiency of investigated drugs, drugs or herbals medicine that may result in toxicity to main organs prior to study start;
- A history or evidence of any of the following :
- Severe hypoglycemia history (e.g., sleepiness, consciousness disorder, deliration, coma led by hypoglycemia);
- Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing's syndrome or acromegaly-associated diabetes);
- Acute or chronic gastrointestinal diseases that were not suitable for the trials evaluated by investigators;
- Hypertension with SBP>140mmHg, and/or DBP >90mmHg after antihypertensive therapy;
- Severe cardiovascular diseases histories including congestive heart failure (NYHA III or IV), unstable angina, stroke or TIA, myocardial infarction,sustained and clinically relevant ventricular arrhythmia, coronary artery bypass surgery or percutaneous coronary intervention;
- Acute or chronic pancreatitis history, or pancreas injury history, or any high risk factors which may result in pancreatitis;
- Malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, regardless of whether there is evidence of local recurrence or metastases;
- Medullary thyroid carcinoma history, or multiple endocrine neoplasia history;
- Acute metabolic complications such as ketoacidosis, lactic acidosis, or hyperosmolar state (coma) , or maculopathy , or instability of proliferative retinopathy within the past 6 months;
- Weight change is over 10% within 3 months prior to the study start;
- Any of the following significant laboratory abnormalities:
- Alanine aminotrasferase (ALT) and/or asparatate aminotransferase (AST)>2*upper limit of normal (ULN), and/or total bilirubin>1.5*ULN, confirmed by repeat measure;
- Creatinine > upper limit of normal, confirmed by repeat measure, and/or proteinurea>++ and 24 hour urinary protein quantitative ≥1g;
- Fasting plasma triglyceride ≥ 5.64 mmol/L (500mg/dL);
- Thyroid dysfunction unsuitable for this trial evaluated by investigator;
- Hemodlastase > upper limit of normal, confirmed by repeat measure;
- Male or female fertility are reluctant to take contraceptive method during the test, pregnancy or lactating women;
- Any other situations which may result in the withdrawal of subjects or bring significant risk to subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Multicenter, Randomized Study Evaluating the Safety, and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 12 Weeks Injection of Polyethylene Glycol Loxenatide Add to Metformin
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 effective therapeutic concentration range of PEX168, also decided to observe safety and PK/PD correlation by long-term continuous administration.
- Conditions
- Type 2 Diabetes
- Being tested
- PEX168 or placebo
- Keywords
- PEX168, Phase I/II, add on to metformin
- 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.
PEX168 or placeboDrug
Also called Polyethylene Glycol Loxenatide or Placebo
injection has to administered subcutaneously weekly
| Study group | Role | What they receive |
|---|---|---|
| PEX168 100 microgram | Experimental | PEX168 100 microgram qw sc. and the medication continued for 12 weeks Receives: Drug: PEX168 or placebo |
| PEX168 200 microgram | Experimental | PEX168 200 microgram qw sc. and the medication continued for 12 weeks Receives: Drug: PEX168 or placebo |
| Placebo | Placebo comparator | Placebo qw sc. and the medication continued for 12 weeks Receives: Drug: PEX168 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess HbA1C levels after treatment
Measured: 12 weeks
Secondary outcomes (1)
To assess Fasting blood glucose levels
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 posted18 Oct 2013 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionOct 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Wenying Yang, M.D, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965509
- Sponsor's protocol ID
- PEX168-I-06
- Status last verified
- Oct 2013
- First submitted
- 12 Jun 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 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, and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 12 Weeks Injection of Polyethylene Glycol Loxenatide Add to Metformin
- ClinicalTrials.gov ID
- NCT01965509
- Acronym / sponsor ID
- PEX168-I-06
- Conditions
- Type 2 Diabetes
- Keywords
- PEX168, Phase I/II, add on to metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Oct 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 effective therapeutic concentration range of PEX168, also decided to observe safety and PK/PD correlation by long-term continuous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEX168 100 microgram | Experimental | Drug: PEX168 or placeboPEX168 100 microgram qw sc. and the medication continued for 12 weeks |
| PEX168 200 microgram | Experimental | Drug: PEX168 or placeboPEX168 200 microgram qw sc. and the medication continued for 12 weeks |
| Placebo | Placebo comparator | Drug: PEX168 or placeboPlacebo qw sc. and the medication continued for 12 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has been diagnosed with type 2 diabetes mellitus.
- Has been treated with a stable dose of metformin monotherapy ≥ 12 weeks before randomization, and metformin dose ≥ 1500 mg / day.
- Has HbA1c of 7.5% to 11.0%(local) at screening. And has HbA1c of 7.0% to 11.0%(Central) before randomization.
- Is 20 to 70 years old, inclusive.
- Has a body mass index (BMI) of 19 kg/m2 to 35 kg/m2, inclusive.
Key exclusion criteria (30 listed)
- Skin test of PEX168 is positive.
- Is currently treated with any of the following excluded medications:
- A history or evidence of any of the following :
- Any of the following significant laboratory abnormalities:
- Male or female fertility are reluctant to take contraceptive method during the test, pregnancy or lactating women;
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 |
|---|---|---|
| PEX168 or placeboAlso: Polyethylene Glycol Loxenatide or Placeboinjection has to administered subcutaneously weekly | Drug | PEX168 100 microgram, PEX168 200 microgram, Placebo |
Primary outcome
To assess HbA1C levels after treatment
Time frame: 12 weeks
1 secondary outcome
To assess Fasting blood glucose levels
Time frame: 12 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 18 Oct 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.
Wenying Yang, M.D principal investigator
China-Japan Friendship 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 of 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 5 inclusion and 30 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 18 Oct 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 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?
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 assess HbA1C levels after treatment (time frame: 12 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 18 Oct 2013.