A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
NCT ID: NCT04663282
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
179 participants
INTERVENTIONAL
2021-02-04
2022-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INS068
Intervention: Drug: INS068 injection
INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
IDeg
Intervention: Drug: insulin Degludec
Insulin Degludec
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Interventions
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INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Insulin Degludec
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Eligibility Criteria
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Inclusion Criteria
* Age is 18-75 years
* Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable locally) for at least 3 months
* Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily dose of ≥ 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD other than metformin should be minimum half of the daily maximal dose according to local labelling or maximum tolerated dose.
* Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of ≤14 days) and insulin treatment for gestational diabetes are allowed.
* HbA1c 7.0-10.0 % (53-85 mmol/mol) (both inclusive)
* BMI 19-40 kg/m2 (both inclusive)
* Systemic or intra-articular corticosteroids treatment within the last 3 months.
Exclusion Criteria
* Severe hypoglycemia during the previous 6 months.
* Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months.
* Cardiovascular disease within the last 12 months, defined as: stroke, decompensated heart failure (New York Heart Association \[NYHA\] class III or IV), myocardial infarction, or hospitalization for unstable angina pectoris or transient ischemic attack.
* Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer, polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or relapse of cancer.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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National Research Institute - Huntington Park
Huntington Park, California, United States
Clinical Trials Research
Lincoln, California, United States
Torrance Clinical Research Institute Inc
Lomita, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Endocrinology Associates, Inc
Columbus, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Juno Research, LL
Houston, Texas, United States
Juno Research, LLC - Medical Center Office
Houston, Texas, United States
Juno Research, LLC - Southwest Houston Site
Houston, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Core Research Group Pty Ltd
Brisbane, Queensland, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Austin Health (Heidelberg Repatriation Hospital)
Melbourne, Victoria, Australia
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Hainan General Hospital
Haikou, Hainan, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Countries
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Other Identifiers
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INS068-201
Identifier Type: -
Identifier Source: org_study_id