A PK/PD Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
China-Japan Friendship Hospital
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01965509
First received: June 12, 2013
Last updated: October 15, 2013
Last verified: October 2013
  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 the effective therapeutic concentration range of PEX168, also decided to observe safety and PK/PD correlation by long-term continuous administration.


Condition Intervention Phase
Type 2 Diabetes
Drug: PEX168 or placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess HbA1C levels after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess Fasting blood glucose levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To assess the body weights after the treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: August 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 12 weeks
Drug: PEX168 or placebo
injection has to administered subcutaneously weekly
Other Name: Polyethylene Glycol Loxenatide or Placebo
Experimental: PEX168 200 microgram
PEX168 200 microgram qw sc. and the medication continued for 12 weeks
Drug: PEX168 or placebo
injection has to administered subcutaneously weekly
Other Name: Polyethylene Glycol Loxenatide or Placebo
Placebo Comparator: Placebo
Placebo qw sc. and the medication continued for 12 weeks
Drug: PEX168 or placebo
injection has to administered subcutaneously weekly
Other Name: Polyethylene Glycol Loxenatide or Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has been diagnosed with type 2 diabetes mellitus.
  2. Has been treated with a stable dose of metformin monotherapy ≥ 12 weeks before randomization, and metformin dose ≥ 1500 mg / day.
  3. Has HbA1c of 7.5% to 11.0%(local) at screening. And has HbA1c of 7.0% to 11.0%(Central) before randomization.
  4. Is 20 to 70 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 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;
  3. 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;
  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;
    • 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;
  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965509

Locations
China
China-Japan Friendship Hospital
Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
China-Japan Friendship Hospital
Investigators
Principal Investigator: Wenying Yang, M.D China-Japan Friendship Hospital
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01965509     History of Changes
Other Study ID Numbers: PEX168-I-06
Study First Received: June 12, 2013
Last Updated: October 15, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
PEX168
Phase I/II
add on to metformin

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

ClinicalTrials.gov processed this record on October 01, 2014