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The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INS068 injection | Experimental |
| |
| Insulin Glargine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS068 injection | Drug | INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment | Week 0 to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FPG(fasting plasma glucose) | Change from baseline in FPG after 26 weeks and 52 weeks of treatment | Week 0 to Week 26, Week 0 to Week 52 |
| Proportion of Subjects with HbA1c<7% and HbA1c≤6.5% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
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| Insulin Glargine | Drug | Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial |
|
Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks and 52 weeks of treatment
| Week 0 to Week 26 、Week 0 to Week 52 |
| Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period | Week 0 to Week 26, Week 0 to Week 52 |
| Change in HbA1c | Week 0 to Week 52 |
| per-breakfast SMPG | Week 0 to Week 26 、Week 0 to Week 52 |
| 8-point SMPG profiles | Week 0 to Week 26 、Week 0 to Week 52 |
| Average daily Insulin dose | Week 0 to Week 26 、Week 0 to Week 52 |
| Proportion of Subjects requiring rescue therapy during treatment | Week 0 to Week 26 、Week 0 to Week 52 |
| Frequency and severity of adverse events | Week 0 to Week 52 + 14 days follow-up |
| Incidence and rate of Hypoglycemic events | Week 0 to Week 52 + 14 days follow-up |
| Change in weight | Week 0 to Week 26、Week 0 to Week 52 |
| Anti-drug Antibodies | Week 0 to Week 52 + 14 days follow-up |
| Serum INS068 concentration | Week 0 to Week 52 |
| Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs) | Week 0 to Week 26 、Week 0 to Week 52 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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