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

A Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial Comparing the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Basal Insulin

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: INS068 injection; Drug: Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with type 2 diabetes≥ 6 months;
2. HbA1c 7.0% ~ 10.0% (Both inclusive) at screening;
3. Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.

Exclusion Criteria:

1. Known or suspected allergy or intolerance to investigational medicinal products or related products.
2. Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
3. Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
4. Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
5. 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.
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; Anycircumstances that the investigator judges might not be suitable to participate in the trial..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IGlar	Drug: Insulin Glargine; Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Experimental: INS068	Drug: INS068 injection; INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment	Week 0 to Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FPG(fasting plasma glucose)	Change from baseline in FPG after 26 weeks of treatment	Week 0 to Week 26
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%	Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks of treatment	Week 0 to Week 26
per-breakfast SMPG	Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment	Week 0 to Week 26
8-point SMPG profiles		Week 0 to Week 26
Average daily Insulin dose	Average daily Insulin dose after 26 weeks of treatment.	Week 0 to Week 26
Proportion of Subjects requiring rescue therapy during treatment	Proportion of subejcts requiring rescue therapy during 26 weeks of treatment	Week 0 to Week 26
Frequency and severity of adverse events	Severity (mild, moderate and severe) is assessed by investigator.	Week 0 to Week26 +14 days follow-up
Incidence and rate of Hypoglycemic events	Incidence and rate of of Hypoglycemic events	Week 0 to Week 26+14 days follow-up
Change in weight	Change from baseline in weight after 26weeks of treatment	Week 0 to Week 26
Anti-drug Antibodies	Number of subjects with Positive Anti-drug Antibodies	Week 0 to Week26 + 14 days follow-up
Serum INS068 concentration	To evaluate PK of INS068	Week 0 to Week 26
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)	Change from baseline in scores of DTSQs after 26 weeks of treatment.	Week 0 to Week 26

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin Glargine
• Other Study ID Numbers: INS068-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No