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The study is being conducted to evaluate the efficacy and safety of IND068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with one or two oral antidiabetics compared to insulin degludec QD for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INS068 | Experimental | Intervention: Drug: INS068 injection |
|
| IDeg | Active Comparator | Intervention: Drug: insulin Degludec |
|
| 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 16 weeks of treatment | Week 0 to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reaching HbA1c targets | HbA1c <7% or HbA1c ≤6.5% | Week 0 to Week 16 |
| Change in FPG | Change from baseline in FPG after 16 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Institute - Huntington Park | Huntington Park | California | 90255 | United States | ||
| Clinical Trials Research |
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INS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics
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| Insulin Degludec | Drug | Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial |
|
| Week 0 to Week 16 |
| 9-point SMPG profiles | Mean plasma glucose, Postprandial and nocturnal increments, Fluctuation of 9-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime, at 4 am and before breakfast. | Week 0 to Week 16 |
| Pre-breakfast SMPG | Mean plasma glucose, Within-subject variability of pre-breakfast SMPG. | Week 0 to Week 16 |
| Titration target | Proportion of subjects and time reaching titration targets | Week 0 to Week 16 |
| Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication | Classification of hypoglycaemia: Level 1(glucose level below 3.9 mmol/L), Level 2(glucose level below 3.0 mmol/L) and Level 3(Severe hypoglycemia, denotes severe cognitive impairment requiring external assistance for recovery). | Week 0 to Week 16 |
| Numbers of injection site reactions | The injection site reactions was assessed during the treatment period of 16 weeks. | Week 0 to Week 16 |
| Frequency and severity of adverse events | Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities, no or minimal medical treatment. Moderate: marked symptoms, interference with subject's daily activities,and medical treatment for alleviation without grave or permanent injury to the subject. . Severe: considerable interference with subject's daily activities, and intensive treatment and intervention needed. | Week 0 to Week 16 + 14 days follow-up |
| Anti-drug Antibodies: Anti-INS068 Antibodies | Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported. | Week 0 to Week 16+14 days follow-up |
| Changes in Body Weight | Change of body weight was evaluated from Week 0 to Week 16 | Week 0 to Week 16 |
| Changes in Body Mass Index | Change of Body Mass Index was evaluated from Week 0 to Week 16 | Week 0 to Week 16 |
| Change in Health Related Quality of Life Questionnaire (SF -36) | Change from baseline in scores of Health-Related Quality of Life Questionnaire after 16 weeks of treatment. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score) | Week 0 to Week 16 |
| Serum INS068 concentration | To evaluate PK of INS068 | Week 0 to Week 16 |
| Lincoln |
| California |
| 95648 |
| United States |
| Torrance Clinical Research Institute Inc | Lomita | California | 90717 | United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| ALL Medical Research, LLC | Cooper City | Florida | 33024 | United States |
| New Generation of Medical Research | Hialeah | Florida | 33016 | United States |
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014-3616 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Endocrinology Associates, Inc | Columbus | Ohio | 43201 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Juno Research, LL | Houston | Texas | 77040 | United States |
| Juno Research, LLC - Medical Center Office | Houston | Texas | 77054 | United States |
| Juno Research, LLC - Southwest Houston Site | Houston | Texas | 77074 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Core Research Group Pty Ltd | Brisbane | Queensland | 4064 | Australia |
| The Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| Austin Health (Heidelberg Repatriation Hospital) | Melbourne | Victoria | 3081 | Australia |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| Chongqing University Three Gorges Hospital | Chongqing | Chongqing Municipality | 404100 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology | Wuhan | Hubei | 430030 | China |
| Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Affiliated to Southeast University | Nanjing | Jiangsu | 210009 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Shengjing Hospital Of China Medical University | Shenyang | Liaoning | 110004 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| Shanghai Putuo District Central Hospital | Shanghai | Shanghai Municipality | 200062 | China |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610000 | China |
| Yibin Second People's Hospital | Yibin | Sichuan | 644000 | China |
| 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 |
|---|---|
| C571886 | insulin degludec |
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