To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.

NCT05702073 | Completed Phase 3

• 1 other identifier: INS068-301
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.

Conditions

Type 2 Diabetes Mellitus

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 (12)

• Change in FPG(fasting plasma glucose)

  Week 0 to Week 26

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

  Week 0 to Week 26

• per-breakfast SMPG

  Week 0 to Week 26

• 8-point SMPG profiles

  Week 0 to Week 26

• Average daily Insulin dose

  Week 0 to Week 26

Study Arms (2)

INS068

EXPERIMENTAL

Drug: INS068 injection

IGlar

ACTIVE COMPARATOR

Drug: Insulin Glargine

Interventions

INS068 injection DRUG

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

INS068

Insulin Glargine DRUG

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

IGlar

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;
• HbA1c 7.0% \~ 10.0% (Both inclusive) at screening;
• Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.

You may not qualify if:

• Known or suspected allergy or intolerance to investigational medicinal products or related products.
• Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
• Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
• Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
• Participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, 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; Anycircumstances that the investigator judges might not be suitable to participate in the trial..

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, 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 19, 2023
• First Posted: January 27, 2023
• Study Start: March 31, 2023
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (1)