A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics

Completed · Phase 2

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT04663282

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

179

Starts

2021-02-04

Expected to finish

2022-05-28

Last updated by the study team

2022-12-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that will not have been performed during normal management of the subject.)
• 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)

You may not qualify if…

• Known or suspected allergy or intolerance to the active substance or to any of the excipients of the investigational medical products
• 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.
• Any antidiabetic medication other than permitted in the inclusion criteria or any weight-loss drug within the last 8 weeks..
• Systemic or intra-articular corticosteroids treatment within the last 3 months.

Where it is running

• 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

Full record on ClinicalTrials.gov

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