NCT01976858

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 the PK, PD and safety by 8-week continuous treatment of PEX168.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
Last Updated

November 6, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

October 22, 2013

Last Update Submit

October 30, 2013

Conditions

Type 2 Diabetes

Keywords

PEX168, diabetes, phase I

Outcome Measures

Primary Outcomes (1)

  • To determine serum concentrations of PEX168

    8 weeks

Secondary Outcomes (1)

  • To determin HbA1c levels of PEX168

    8 weeks

Other Outcomes (1)

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

    8 weeks

Study Arms (5)

PEX168 50 microgram

EXPERIMENTAL

PEX168 50 microgram qw sc. and the medication continued for 8 weeks

Drug: PEX168

PEX168 100 microgram

EXPERIMENTAL

PEX168 100 microgram qw sc. and the medication continued for 8 weeks

Drug: PEX168

PEX168 200 microgram

EXPERIMENTAL

PEX168 200 microgram qw sc. and the medication continued for 8 weeks

Drug: PEX168

PEX168 300 microgram

EXPERIMENTAL

PEX168 300 microgram qw sc. and the medication continued for 8 weeks

Drug: PEX168

Placebo

PLACEBO COMPARATOR

Placebo qw sc. and the medication continued for 12 weeks

Drug: PEX168

Interventions

PEX168DRUG

A injection administered subcutaneously

Also known as: Polyethylene Glycol Loxenatide
PEX168 100 microgramPEX168 200 microgramPEX168 300 microgramPEX168 50 microgramPlacebo

Eligibility Criteria

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

You may qualify if:

  • aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.
  • HbA1C 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/L after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone).
  • unused insulin within 3 months prior to the enrollment.
  • Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.
  • Normol liver, kidney, heart function.
  • Willing to use physical means of contraception during the trial stage.
  • voluntarily to participate in the study.

You may not qualify if:

  • diabetes.
  • used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.
  • have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history
  • There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.
  • with severe diabetes complications ( renal , retinal , nerve , vascular disease).
  • has acute and chronic pancreatitis history ;
  • heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ;
  • There is a history of hypertension and blood pressure is not well controlled : SBP\> 160mmHg and / or DBP\> 95mmHg persons ;
  • severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ;
  • There are obvious blood system diseases ;
  • There are other endocrine system diseases , such as hyperthyroidism , etc. ;
  • with severe trauma or surgery , severe infection ;
  • have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ;
  • used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ;
  • within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing tongren hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

polyethylene glycol loxenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jinkui Yang, Ph.D, M.D

    Beijing Tongren Hospital

    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

October 22, 2013

First Posted

November 6, 2013

Study Start

June 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

November 6, 2013

Record last verified: 2013-10

Locations

CN(1)