To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs

NCT ID: NCT05699408

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 513 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-11-23

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INS068 injection

Group Type: EXPERIMENTAL

INS068 injection

Intervention Type: DRUG

INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial

Insulin Glargine

Group Type: ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type: DRUG

Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial

Interventions

INS068 injection

INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial

Intervention Type: DRUG

Insulin Glargine

Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes ≥ 6 months；

2. Stable daily dose(s) for ≥8 weeks prior to screening of any of the following anti-diabetic drug(s) or combination regimen(s): 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any of the following oral antidiabetic drugs with dose ≥half of the maximum approved dose according to local label or maximum tolerated): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones and Alpha-glucosidase inhibitors.

3. Glycated hemoglobin was 7.0%~11.0% (both inclusive) at screening

Exclusion Criteria

1. Known or suspected allergy or intolerance to the investigational medicinal products or related products；

2. Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；

3. Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；

4. Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.

5. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 1 month or 5 half-lives, whichever is longer, prior to screening;

6. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug;

7. Any conditions that the Investigator judges might not besuitable to participate in the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

INS068-302

Identifier Type: -

Identifier Source: org_study_id