NCT01965496

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Mar 2012

Typical duration for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

June 12, 2013

Last Update Submit

October 15, 2013

Conditions

Type 2 Diabetes

Keywords

PEX168Phase Ititration

Outcome Measures

Primary Outcomes (1)

  • To assess HbA1C levels after 14 weeks continuous treatment

    14 weeks

Secondary Outcomes (1)

  • To assess Fasting blood glucose levels

    14 weeks

Other Outcomes (2)

  • To assess number of participants with Adverse Events as a Measure of Safety and Tolerability

    14 weeks

  • To assess the body weights after the treatment

    14 weeks

Study Arms (3)

PEX168 100 microgram

EXPERIMENTAL

PEX168 100 microgram qw sc. and the medication continued for 14 weeks

Drug: PEX168

PEX168 200 microgram

EXPERIMENTAL

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

PEX168 300 microgram

EXPERIMENTAL

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

Interventions

PEX168DRUG

A injection administered subcutaneously

Also known as: Polyethylene Glycol Loxenatide
PEX168 100 microgramPEX168 200 microgramPEX168 300 microgram

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has been diagnosed with type 2 diabetes mellitus
  • 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.
  • Has HbA1c of 7.5% to 11.0%, inclusive.
  • Is 20 to 72 years old, inclusive.
  • Has a body mass index (BMI) of 19 kg/m2 to 35 kg/m2, inclusive.

You may not qualify if:

  • 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;
  • 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 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.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Liberation Army General Hospital of Chengdu Military Region

Chengdu, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Xiaolan Yong, M.D

    People's Liberation Army General Hospital of Chengdu Military Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2013

First Posted

October 18, 2013

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

CN(1)