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

This study has been completed.
Sponsor:
Collaborator:
People's Liberation Army General Hospital of Chengdu Military Region
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01965496
First received: June 12, 2013
Last updated: October 15, 2013
Last verified: October 2013

June 12, 2013
October 15, 2013
March 2012
March 2013   (final data collection date for primary outcome measure)
To assess HbA1C levels after 14 weeks continuous treatment [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01965496 on ClinicalTrials.gov Archive Site
To assess Fasting blood glucose levels [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Same as current
  • To assess number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
  • To assess the body weights after the treatment [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Same as current
 
A Phase I Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
Drug: PEX168
A injection administered subcutaneously
Other Name: Polyethylene Glycol Loxenatide
  • Experimental: PEX168 100 microgram
    PEX168 100 microgram qw sc. and the medication continued for 14 weeks
    Intervention: Drug: PEX168
  • 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.
    Intervention: Drug: PEX168
  • 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.
    Intervention: Drug: PEX168
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01965496
PEX168-I-05
No
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
People's Liberation Army General Hospital of Chengdu Military Region
Principal Investigator: Xiaolan Yong, M.D People's Liberation Army General Hospital of Chengdu Military Region
Jiangsu HengRui Medicine Co., Ltd.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP