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

NCT05699408 | Completed Phase 3

• 1 other identifier: INS068-302
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment

  Week 0 to Week 26

Secondary Outcomes (14)

• Change in FPG(fasting plasma glucose)

  Week 0 to Week 26, Week 0 to Week 52

• Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%

  Week 0 to Week 26 、Week 0 to Week 52

• Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period

  Week 0 to Week 26, Week 0 to Week 52

• Change in HbA1c

  Week 0 to Week 52

• per-breakfast SMPG

  Week 0 to Week 26 、Week 0 to Week 52

Study Arms (2)

INS068 injection

EXPERIMENTAL

Drug: INS068 injection

Insulin Glargine

ACTIVE COMPARATOR

Drug: Insulin Glargine

Interventions

INS068 injection DRUG

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

INS068 injection

Insulin Glargine DRUG

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

Insulin Glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes ≥ 6 months；
• 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.
• Glycated hemoglobin was 7.0%\~11.0% (both inclusive) at screening

You may not qualify if:

• Known or suspected allergy or intolerance to the investigational medicinal products or related products；
• Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；
• Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；
• Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.
• 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;
• 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;
• Any conditions that the Investigator judges might not besuitable to participate in the trial.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: March 31, 2023
• Primary Completion: November 23, 2024
• Study Completion: November 23, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CN (1)