NCT01965509

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 effective therapeutic concentration range of PEX168, also decided to observe safety and PK/PD correlation by long-term continuous administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
17 days 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

1.3 years

First QC Date

June 12, 2013

Last Update Submit

October 15, 2013

Conditions

Type 2 Diabetes

Keywords

PEX168Phase I/IIadd on to metformin

Outcome Measures

Primary Outcomes (1)

  • To assess HbA1C levels after treatment

    12 weeks

Secondary Outcomes (1)

  • To assess Fasting blood glucose levels

    12 weeks

Other Outcomes (2)

  • To assess the body weights after the treatment

    12 weeks

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

    12 weeks

Study Arms (3)

PEX168 100 microgram

EXPERIMENTAL

PEX168 100 microgram qw sc. and the medication continued for 12 weeks

Drug: PEX168 or placebo

PEX168 200 microgram

EXPERIMENTAL

PEX168 200 microgram qw sc. and the medication continued for 12 weeks

Drug: PEX168 or placebo

Placebo

PLACEBO COMPARATOR

Placebo qw sc. and the medication continued for 12 weeks

Drug: PEX168 or placebo

Interventions

PEX168 or placeboDRUG

injection has to administered subcutaneously weekly

Also known as: Polyethylene Glycol Loxenatide or Placebo
PEX168 100 microgramPEX168 200 microgramPlacebo

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 a stable dose of metformin monotherapy ≥ 12 weeks before randomization, and metformin dose ≥ 1500 mg / day.
  • Has HbA1c of 7.5% to 11.0%(local) at screening. And has HbA1c of 7.0% to 11.0%(Central) before randomization.
  • Is 20 to 70 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 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;
  • 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;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 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

  • Wenying Yang, M.D

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

CN(1)