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Type 2 Diabetes MellitusPhase 3NCT02477969

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

A Phase 3 study testing PEX168(100µg), PEX168(200µg) and Metformin in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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… 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), PEX168(200µg) and Metformin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
587 participants
Where
1 siteChina
Study dates
27 Feb 2014to Jun 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 metformin monotherapy received prior to screening
  • No glucose-lowering medications other than metformin received within the 8 weeks prior to screening
Show all 45Show fewer
  • 7.5%≤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
  • Exclusion criteria (subject to be excluded if meeting any of the followings)
  • 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
  • History of severe hypoglycemic episode, or severe hypoglycemia without symptoms
  • Significant hematological disorders , or any diseases that may lead to hemolysis or unstable RBC
  • Severe diabetic complications (e.g., macrovascular and microvascular 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 have or have not been treated within the 5 years prior to screening, regardless of whether there is evidence of relapse or metastasis, with the exception of local basal cell carcinoma of the skin
  • Coronary angioplasty, coronary stenting, coronary artery bypass, uncompensated heart failure （NYHA Class III or IV）, stroke or transient cerebral ischemic attack, unstable angina, myocardial infarction, and persistent and clinically significant arrhythmia, experienced within the 6 months prior to screening
  • Acute metabolic complications (e.g., ketoacidosis, lactic acidosis, hyperosmolar coma) within the 6 months prior to screening
  • Thyroid dysfunction treated with unstable therapeutic doses (e.g., thioureas, thyroid hormones) within the 6 months prior to screening
  • Blood lipid disorders treated with unstable therapeutic doses (e.g., statins, fibrates) within the 6 months prior to screening
  • Any severe trauma or severe infection that may interfere with BG control within the 1 month prior to screening
  • Laboratory indicators meeting any of the following criteria prior to screening (any test meeting the criteria must be repeated within 3 work days for confirmation)
  • 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 that at the investigator's discretion may confound the interpretation of the efficacy or safety data
  • Clinically significant 12-lead ECG abnormalities, e.g., Grade II or III atrial ventricular block （with the exception of right bundle branch block），long QT syndrome or QTc>500ms
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）Combined With Metformin in the Treatment of Type 2 Diabetes Mellitus

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).

Read the detailed description

Subjects will be randomized to receive either PEX168 100μg, 200μg or PEX 168 Dummy Injection as add-on to metformin hydrochloride. The baseline HbA1c level （HbA1c≤8.5% or HbA1c>8.5）is designed as the stratification factor based on which a dynamic randomization will be performed.

This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A 4-week PEX168 dummy injection 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 30-day safety follow-up period.

Being tested
PEX168(100µg), PEX168(200µg), Placebo, Metformin
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

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

  • PEX168(200µg)Drug

    Also called Polyethylene Glycol Loxenatide

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

  • PlaceboDrug

    Also called PEGylated Loxenatide Injection Mimetics

    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.

  • MetforminDrug

    Also called ge hua zhi

    0.5mg,oral,tid.

Study groups in NCT02477969
Study groupRoleWhat they receive
PEX168(100µg)ExperimentalPEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Receives: Drug: PEX168(100µg); Drug: Metformin
PEX168(200µg)ExperimentalPEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Receives: Drug: PEX168(200µg); Drug: Metformin
PlaceboPlacebo comparatorPlacebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Receives: Drug: Placebo; Drug: Metformin

What is being measured

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

  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.

    Measured: Baseline to Week24

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: Baseline to Week24

  2. Fasting plasma glucose

    Measured: Baseline to Week52

  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: Baseline to Week52

  4. Postprandial blood glucose two hours

    Measured: Baseline to Week52

  5. Postprandial blood glucose two hours AUC

    Measured: Baseline to Week52

  6. Lipid

    Measured: Baseline to Week52

  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: Baseline to Week52

  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: Baseline to Week52

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

    Measured: Baseline to Week 56

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 start27 Feb 2014
  3. Primary completion22 Jun 2016
  4. Study completionJun 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
587 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477969
Sponsor's protocol ID
PEX168-302
Status last verified
Jan 2016
First submitted
30 May 2015
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEX168(100µg), PEX168(200µg) and Metformin in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

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 45 inclusion and 0 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.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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: Baseline to Week24). 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 NCT02477969.

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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