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

Type 2 Diabetes Mellitus 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 Basal Insulin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702073
• Other study ID #: INS068-301
• Status: Recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: January 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Miaomiao Shi
• Phone: +8618036617171
• Email: miaomiao.shi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 23, 2024
• Est. primary completion date: October 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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..

Related Conditions & MeSH terms

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

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	Zhongshan Hospital	Shanghai	Shanghai

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 of treatment	Week 0 to Week 26
Secondary	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
Secondary	per-breakfast SMPG	Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment	Week 0 to Week 26
Secondary	8-point SMPG profiles		Week 0 to Week 26
Secondary	Average daily Insulin dose	Average daily Insulin dose after 26 weeks of treatment.	Week 0 to Week 26
Secondary	Proportion of Subjects requiring rescue therapy during treatment	Proportion of subejcts requiring rescue therapy during 26 weeks of treatment	Week 0 to Week 26
Secondary	Frequency and severity of adverse events	Severity (mild, moderate and severe) is assessed by investigator.	Week 0 to Week26 +14 days follow-up
Secondary	Incidence and rate of Hypoglycemic events	Incidence and rate of of Hypoglycemic events	Week 0 to Week 26+14 days follow-up
Secondary	Change in weight	Change from baseline in weight after 26weeks of treatment	Week 0 to Week 26
Secondary	Anti-drug Antibodies	Number of subjects with Positive Anti-drug Antibodies	Week 0 to Week26 + 14 days follow-up
Secondary	Serum INS068 concentration	To evaluate PK of INS068	Week 0 to Week 26
Secondary	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