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A Phase I Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01965496
First Posted: October 18, 2013
Last Update Posted: October 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
People's Liberation Army General Hospital of Chengdu Military Region
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
  Purpose

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 whether the titration mode of administration could reduce the incidence of adverse reactions of PEX168, also decided to observe long-term continuous administration of PK/PD correlation.


Condition Intervention Phase
Type 2 Diabetes Drug: PEX168 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter, Randomized Study Evaluating the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 14 Weeks Injection of Polyethylene Glycol Loxenatide

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • To assess HbA1C levels after 14 weeks continuous treatment [ Time Frame: 14 weeks ]

Secondary Outcome Measures:
  • To assess Fasting blood glucose levels [ Time Frame: 14 weeks ]

Other Outcome Measures:
  • To assess number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 weeks ]
  • To assess the body weights after the treatment [ Time Frame: 14 weeks ]

Enrollment: 64
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEX168 100 microgram
PEX168 100 microgram qw sc. and the medication continued for 14 weeks
Drug: PEX168
A injection administered subcutaneously
Other Name: Polyethylene Glycol Loxenatide
Experimental: PEX168 200 microgram
PEX168 200 microgram qw sc. and the medication start form 100 microgram qw for 4 weeks and then increased to 200 microgram qw for the 10 weeks.
Drug: PEX168
A injection administered subcutaneously
Other Name: Polyethylene Glycol Loxenatide
Experimental: PEX168 300 microgram
PEX168 300 microgram qw sc. and the medication start form 100 microgram qw for 4 weeks and then increased to 300 microgram qw for the 10 weeks.
Drug: PEX168
A injection administered subcutaneously
Other Name: Polyethylene Glycol Loxenatide

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has been diagnosed with type 2 diabetes mellitus
  2. Has been treated with either: diet and exercise alone, or with a stable regimen of one or combination of two oral antihyperglycaemic agents (except TZDs), for a minimum of 3 months prior to study start.
  3. Has HbA1c of 7.5% to 11.0%, inclusive.
  4. Is 20 to 72 years old, inclusive.
  5. Has a body mass index (BMI) of 19 kg/m2 to 35 kg/m2, inclusive.

Exclusion Criteria:

  1. Skin test of PEX168 is positive.
  2. 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;
    • 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;
  3. A history or evidence of any of the following :

    • Severe hypoglycemia history (e.g., sleepiness, consciousness disorder, deliration, coma led by hypoglycemia )
    • Type 1diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing's syndrome or acromegaly-associated diabetes).
    • Other endocrine diseases (e.g., hyperthyreosis, hypothyroidism)
    • 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.
    • hepatitis B positive, hepatitis C antibody positive, HIV antibody positive, syphilis antibody positive.
  4. 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.
    • Thyroid dysfunction unsuitable for this trial evaluated by investigator;
    • Hemodlastase > upper limit of normal, confirmed by repeat measure;
  5. Male or female fertility are reluctant to take contraceptive method during the test, pregnancy or lactating women;
  6. Any other situations which may result in the withdrawal of subjects or bring significant risk to subjects.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965496


Locations
China
People's Liberation Army General Hospital of Chengdu Military Region
Chengdu, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
People's Liberation Army General Hospital of Chengdu Military Region
Investigators
Principal Investigator: Xiaolan Yong, M.D People's Liberation Army General Hospital of Chengdu Military Region
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01965496     History of Changes
Other Study ID Numbers: PEX168-I-05
First Submitted: June 12, 2013
First Posted: October 18, 2013
Last Update Posted: October 18, 2013
Last Verified: October 2013

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
PEX168
Phase I
titration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases