NCT04663282

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

Evaluation of the Efficacy and Safety of INS068 Injection and Insulin Degludec Subcutaneous Injection Once Daily in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With One or Two Oral Antidiabetics (A Randomized, Open-Label, Two-Arm, Treat-to-Target, Parallel Controlled Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	INS068 injection	INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
DRUG	Insulin Degludec	Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-05-28
• Completion: 2022-05-28
• First posted: 2020-12-10
• Last updated: 2022-12-21

Locations

35 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study