Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients

NCT02477865 | Unknown Phase 3

• 1 other identifier: PEX168-301
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning to include approximately 387 T2DM patients who have received at least 8 weeks of treatment with diet control and exercise； have not received any glucose-lowering agents within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The subjects would receive PEX168 or placebo monotherapy for 52weeks in total.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  To evaluate the HbA1c change from baseline to treatment Week 24 when receiving PEX 168 as compared to the placebo, given on the basis of diet control and exercise.

  Baseling to 24 weeks

Secondary Outcomes (9)

• The proportion of HbA1c <6.5% and <7% at the end of the analysis.

  Baseling to 24 weeks

• Fasting plasma glucose

  Baseling to 52 weeks

• 6 points glucose of fingertip

  Baseling to 24 and 52 weeks

• Postprandial blood glucose two hours

  Baseling to 24 weeks

• Postprandial blood glucose two hours AUC

  Baseling to 24 weeks

Study Arms (3)

PEX168(100µg)

EXPERIMENTAL

PEX168(100µg),100µg,Subcutaneous injection,once a week,for 52 weeks.

Drug: PEX168(100µg)

PEX168(200µg)

EXPERIMENTAL

PEX168(200µg),200µg,Subcutaneous injection,once a week,for 52 weeks.

Drug: PEX168(200µg)

Placebo

PLACEBO COMPARATOR

Placebo,0.5ml,Subcutaneous injection,once a week for 24 weeks,followed by PEX168(100µg or 200µg) qw sc for 28 weeks.

Drug: Placebo

Interventions

PEX168(100µg) DRUG

100µg,Subcutaneous injection,once a week. continued for 52 weeks

Also known as: Polyethylene Glycol Loxenatide

PEX168(100µg)

PEX168(200µg) DRUG

200µg,Subcutaneous injection,once a week. continued for 52 weeks

Also known as: Polyethylene Glycol Loxenatide

PEX168(200µg)

Placebo DRUG

0.5ml,Subcutaneous injection,once a week.continued for 24 weeks,then use PEX168 100µg or 200µg qw sc.for 28 weeks.

Also known as: Injection mimetic

Placebo

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus confirmed by the 1999 WHO criteria；
• Men or women；
• Age at signing the ICF≥18 years and ≤78 years；
• Body mass index (BMI) 20-40 Kg/m2；
• At least 8 weeks of treatment with diet control and exercise received prior to screening；
• No glucose-lowering agents received within the 8 weeks prior to screening；
• %≤HbA1c≤11.0% at screening（local or centralized test）； 7.0%≤HbA1c≤10.5% at randomization（centralized test），and FBG\< 13.9 mmol/L（local test）；
• Ability to understand the procedures and approach of this study, willingness to complete the study in strict compliance with the protocol and to voluntarily sign the ICF.

You may not qualify if:

• Investigator suspecting the subject of allergy to the study drug；
• Use of any of the following medications or therapies prior to screening：
• GLP-1 receptor agonists, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues.
• Growth hormone therapy within the 6 months prior to screening；
• History of drug abuse or alcohol abuse；
• Participation in any clinical trial within the 3 months prior to screening；
• Prolonged intravenous, oral or intraarticular treatment with corticosteroids within the 2 months prior to screening;
• Use of any weight control agents or surgeries within the 2 months prior to screening;
• Any medications used prior to screening that at the investigator's discretion may confound the interpretation of the efficacy or safety data；
• History or evidence of any of the following conditions prior to screening：
• Type 1 diabetes mellitus, single gene mutation DM, DM associated with pancreatic injury，or secondary DM；
• History of hypertension with SBP\>160 mmHg and/or DBP\>100 mmHg；
• History of acute/chronic pancreatitis, history of symptomatic cholecystopathy;
• History of myeloid C-cell carcinoma, history of multiple endocrine neoplasm （MEN） 2A or 2B syndrome, or related familiar history；
• Gastric emptying disorders, severe chronic gastrointestinal disorders;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wenying Yang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 23, 2015
• Study Start: March 23, 2014
• Primary Completion: May 15, 2016
• Study Completion: February 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share