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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEX168(100µg) | Experimental | PEX168(100µg),100µg,Subcutaneous injection,once a week,for 52 weeks. |
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| PEX168(200µg) | Experimental | PEX168(200µg),200µg,Subcutaneous injection,once a week,for 52 weeks. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEX168(100µg) | Drug | 100µg,Subcutaneous injection,once a week. continued for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseling to 24 weeks |
| Fasting plasma glucose |
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Inclusion Criteria (all of the 8 must be met):
Exclusion criteria:
Investigator suspecting the subject of allergy to the study drug;
Use of any of the following medications or therapies prior to screening:
History or evidence of any of the following conditions prior to screening:
Laboratory indicators meeting any of the following criteria prior to screening:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Wenying Yang, MD | China-Japan Friendship Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601947 | polyethylene glycol loxenatide |
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| PEX168(200µg) | Drug | 200µg,Subcutaneous injection,once a week. continued for 52 weeks |
|
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| Placebo | Drug | 0.5ml,Subcutaneous injection,once a week.continued for 24 weeks,then use PEX168 100µg or 200µg qw sc.for 28 weeks. |
|
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| Baseling to 52 weeks |
| 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. | 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 |
| Lipid | Baseling to 52 weeks |
| 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. | Baseling to 52 weeks |
| Blood pressure | Collect blood pressure data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure. | Baseling to 52 weeks |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Baseling to 56 weeks |
| D004700 | Endocrine System Diseases |