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Type 2 Diabetes MellitusPhase 3NCT02477865

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

A Phase 3 study testing PEX168(100µg) and PEX168(200µg) in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
PEX168(100µg) and PEX168(200µg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
No sites listed yet
Study dates
23 Mar 2014to Feb 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
  • 7.5%≤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.

Who cannot join

  • 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；
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  • 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;
  • History of severe hypoglycemia, unconsciousness or severe hypoglycemia history；
  • Significant hematological disorders, or any diseases；
  • Severe diabetic complications that in the opinion of the investigator make the subject not suitable to participate in this study；
  • Tumors of any organ or system that not been treated within the 5 years prior to screening；
  • Coronary angioplasty, coronary stenting, coronary artery bypass, uncompensated heart failure （NYHA Class III or IV）, within the 6 months prior to screening；
  • Acute metabolic complications within the 6 months prior to screening；
  • Thyroid dysfunction within the 6 months prior to screening；
  • Blood lipid disorders within the 6 months prior to screening；
  • Any severe trauma or severe infection within the 1 month prior to screening；
  • Laboratory indicators meeting any of the following criteria prior to screening：
  • ALT>2.5×ULN and/or AST>2.5×ULN and/or total bilirubin>2.5×ULN；
  • Hemoglobin≤100 g/L；
  • Serum creatinine>1.5×UNL and eGFR < 45 ml/min/1.73 m2； eGFR is calculated as：186.3 ×[（Serum Creatinine（mmol/L）/88.4）]-1.154 × [Age (years)]- 0.203 × 1.223 × 0.742 （Females） or ×1（Males）
  • Serum thyroid-stimulating hormone（TSH） out of the reference range that is assessed as clinically significant by the investigator;
  • Fasting TGL>5.64 mmol/L（500 mg/dl）；
  • Blood amylase and urine amylase>ULN that is assessed as clinically significant by the investigator；
  • Any clinically significant laboratory abnormalities；
  • Clinically significant 12-lead ECG abnormalities；
  • Blood donation or loss≥400 mL，or receipt of blood donation within the 4 weeks prior to screening；
  • Pregnant or lactating women, or men or women of child-bearing potential not willing to take contraceptive measures during the study；
  • Any other conditions of the subject that at the investigator's discretion may compound the interpretation of the efficacy or safety data.

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIIa Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）in Monotherapy of Type 2 Diabetes Mellitus

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.

Read the detailed description

This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A 4-week PEX168 dummy run-in period. Period 3：A 52-week treatment period (including a 24-week core treatment period and a 28-week extended treatment period).

Period 4: A 4-week safety follow-up period. This study will last for approximately 63 weeks, including up to approximately 60 clinic visits.

Being tested
PEX168(100µg), PEX168(200µg), Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEX168(100µg)Drug

    Also called Polyethylene Glycol Loxenatide

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

  • PEX168(200µg)Drug

    Also called Polyethylene Glycol Loxenatide

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

  • PlaceboDrug

    Also called Injection mimetic

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

Study groups in NCT02477865
Study groupRoleWhat they receive
PEX168(100µg)ExperimentalPEX168(100µg),100µg,Subcutaneous injection,once a week,for 52 weeks.
Receives: Drug: PEX168(100µg)
PEX168(200µg)ExperimentalPEX168(200µg),200µg,Subcutaneous injection,once a week,for 52 weeks.
Receives: Drug: PEX168(200µg)
PlaceboPlacebo comparatorPlacebo,0.5ml,Subcutaneous injection,once a week for 24 weeks,followed by PEX168(100µg or 200µg) qw sc for 28 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseling to 24 weeks

Secondary outcomes (9)

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

    The proportion of HbA1c <6.5% and <7% at the end of the analysis, and the proportion receiving salvage therapy.

    Measured: Baseling to 24 weeks

  2. Fasting plasma glucose

    Measured: Baseling to 52 weeks

  3. 6 points glucose of fingertip

    Each test point of time was before breakfast, 2 hours after breakfast, before lunch,2 hours after lunch , dinner, 2 hours after dinner.This test was performed four times including baseline,V19,V31 and V59.

    Measured: Baseling to 24 and 52 weeks

  4. Postprandial blood glucose two hours

    Measured: Baseling to 24 weeks

  5. Postprandial blood glucose two hours AUC

    Measured: Baseling to 24 weeks

  6. Lipid

    Measured: Baseling to 52 weeks

  7. Weight measured by standardized procedure.

    Collect weight data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure.

    Measured: Baseling to 52 weeks

  8. Blood pressure

    Collect blood pressure data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure.

    Measured: Baseling to 52 weeks

  9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Baseling to 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study start23 Mar 2014
  3. Primary completion15 May 2016
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477865
Sponsor's protocol ID
PEX168-301
Status last verified
Jan 2016
First submitted
28 May 2015
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEX168(100µg) and PEX168(200µg) in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Baseling to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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