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

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 Oral Antidiabetic Drugs

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: INS068 injection; Drug: Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 513
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xi Meng; Phone Number: +86-0518-82342973; Email: xi.meng@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's 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. 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.

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
Experimental: INS068 injection	Drug: INS068 injection; INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Active Comparator: Insulin Glargine	Drug: Insulin Glargine; Insulin Glargine 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 and 52 weeks of treatment	Week 0 to Week 26, Week 0 to Week 52
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%	Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks and 52 weeks of treatment	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
8-point SMPG profiles		Week 0 to Week 26 、Week 0 to Week 52
Average daily Insulin dose		Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects requiring rescue therapy during treatment		Week 0 to Week 26 、Week 0 to Week 52
Frequency and severity of adverse events		Week 0 to Week 52 + 14 days follow-up
Incidence and rate of Hypoglycemic events		Week 0 to Week 52 + 14 days follow-up
Change in weight		Week 0 to Week 26、Week 0 to Week 52
Anti-drug Antibodies		Week 0 to Week 52 + 14 days follow-up
Serum INS068 concentration		Week 0 to Week 52
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)		Week 0 to Week 26 、Week 0 to Week 52

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): September 23, 2025
• Study Completion (Estimated): September 23, 2025

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: INS068-302

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