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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05699408
• Other study ID #: INS068-302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: September 23, 2025

Study information

• Verified date: January 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 513
• Est. completion date: September 23, 2025
• Est. primary completion date: September 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
• Insulin Glargine
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment	Week 0 to Week 26
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in HbA1c		Week 0 to Week 52
Secondary	per-breakfast SMPG		Week 0 to Week 26 ?Week 0 to Week 52
Secondary	8-point SMPG profiles		Week 0 to Week 26 ?Week 0 to Week 52
Secondary	Average daily Insulin dose		Week 0 to Week 26 ?Week 0 to Week 52
Secondary	Proportion of Subjects requiring rescue therapy during treatment		Week 0 to Week 26 ?Week 0 to Week 52
Secondary	Frequency and severity of adverse events		Week 0 to Week 52 + 14 days follow-up
Secondary	Incidence and rate of Hypoglycemic events		Week 0 to Week 52 + 14 days follow-up
Secondary	Change in weight		Week 0 to Week 26?Week 0 to Week 52
Secondary	Anti-drug Antibodies		Week 0 to Week 52 + 14 days follow-up
Secondary	Serum INS068 concentration		Week 0 to Week 52
Secondary	Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)		Week 0 to Week 26 ?Week 0 to Week 52