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This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients with Type 2 Diabetes with Inadequately Controlled Blood Glucose Level after Metformin Monotherapy or Metformin in Combination with Insulin Secretagogues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJC-1134-PC | Experimental | Injection, 0.2ml/2mg (prefilled pen) |
|
| Placebo | Placebo Comparator | Injection, 0.2ml/0mg (prefilled pen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJC-1134-PC Injection | Drug | Double-blind Treatment Period: 0.2ml (2mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at the end of double-blind treatment period | The double-blind treatment period ended at the 25-week visit. | Week 25 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with HbA1c <7.0% at the end of the double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Proportion of subjects with HbA1c <6.5% at the end of the double-blind/open-label treatment period. |
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Inclusion Criteria:
Subjects were eligible for the study only if all the following inclusion criteria were met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, Prof. | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| Placebo | Drug | Double-blind Treatment Period: 0.2ml (0mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52) |
|
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. |
| Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting weight at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting waist circumference at the end of double-blind /open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting plasma glucose at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting proinsulin at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting insulin at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting C-peptide at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting lipids (total cholesterol) at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting lipids (low-density lipoprotein [LDL]) at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting lipids (high-density lipoprotein [HDL]) at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting lipids (triglycerides) at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in fasting lipids (LDL/HDL ratio) at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in systolic blood pressure [SBP] at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in diastolic blood pressure [DBP] at the end of double-blind treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in 6-point finger-stick blood glucose at the end of double-blind/open-label treatment period. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in blood AST at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Changes from baseline in blood ALT at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging. | The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit. | Week 25 visit, and week 53 visit. |
| Change from baseline in HbA1c at the end of open-label treatment period. | The open-label treatment period ended at the 53-week visit. | Week 53 visit. |