Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

NCT02477969 | Unknown Phase 3 DMC

• 1 other identifier: PEX168-302
• Study Type: interventional
• Target: 587
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of metformin monotherapy at stable doses（≥1500 mg/day).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c change from baseline to treatment Week 24 when receiving PEX 168 combined with metformin hydrochloride as compared to the placebo combined with metformin hydrochloride；PEX 168 as compared to the placebo, given on the basis of diet control and exercise.

  Baseline to Week24

Secondary Outcomes (9)

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

  Baseline to Week24

• Fasting plasma glucose

  Baseline to Week52

• 6 points glucose of fingertip

  Baseline to Week52

• Postprandial blood glucose two hours

  Baseline to Week52

• Postprandial blood glucose two hours AUC

  Baseline to Week52

Study Arms (3)

PEX168(100µg)

EXPERIMENTAL

PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.

Drug: PEX168(100µg); Drug: Metformin

PEX168(200µg)

EXPERIMENTAL

PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.

Drug: PEX168(200µg); Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.

Drug: Placebo; Drug: Metformin

Interventions

PEX168(100µg) DRUG

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

Also known as: Polyethylene Glycol Loxenatide

PEX168(100µg)

PEX168(200µg) DRUG

PEX168,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 followed by PEX168 100µg,qw sc. or 200µg qw sc.for 28 weeks.

Also known as: PEGylated Loxenatide Injection Mimetics

Placebo

Metformin DRUG

0.5mg,oral,tid.

Also known as: ge hua zhi

PEX168(100µg); PEX168(200µg); 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 metformin monotherapy received prior to screening
• No glucose-lowering medications other than metformin 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)
• 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 for a pharmaceutical product or medical device within the 3 months prior to screening
• Prolonged (for at least 7 consecutive days) intravenous, oral or intraarticular treatment with corticosteroids within the 2 months prior to screening
• Use of any weight control agents or surgeries that might lead to unstable weight within the 2 months prior to screening, or subjects currently on a weight loss plan not in the maintenance phase
• Any medications used prior to screening that at the investigator's discretion may confound the interpretation of the efficacy or safety data, or use of any medications that may cause common toxicities to major organs, including Chinese herbal medicine
• 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, e.g., DM secondary to Cushing syndrome or acromegalia
• History of hypertension with SBP\>160 mmHg and/or DBP\>100 mmHg despite glucose-lowering agents at stable dose (for at least 4 weeks)
• History of acute/chronic pancreatitis, history of symptomatic cholecystopathy, and the risk factors for pancreatitis including pancreatic injury
• History of myeloid C-cell carcinoma, history of multiple endocrine neoplasm （MEN） 2A or 2B syndrome, or related familiar history
• Clinically significant gastric emptying disorders, severe chronic gastrointestinal disorders, prolonged treatment with peristalsis stimulants, or gastrointestinal surgery

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatide; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Weiping Jia, MD

  Shanghai the sixth 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 30, 2015
• First Posted: June 23, 2015
• Study Start: February 27, 2014
• Primary Completion: June 22, 2016
• Study Completion: June 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)