Back to resultsTo Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
Primary Purpose
Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
INS068 injection
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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..
Sites / Locations
- Zhongshan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
INS068
IGlar
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Secondary Outcome Measures
Change in FPG(fasting plasma glucose)
Change from baseline in FPG after 26 weeks of treatment
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
per-breakfast SMPG
Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment
8-point SMPG profiles
Average daily Insulin dose
Average daily Insulin dose after 26 weeks of treatment.
Proportion of Subjects requiring rescue therapy during treatment
Proportion of subejcts requiring rescue therapy during 26 weeks of treatment
Frequency and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator.
Incidence and rate of Hypoglycemic events
Incidence and rate of of Hypoglycemic events
Change in weight
Change from baseline in weight after 26weeks of treatment
Anti-drug Antibodies
Number of subjects with Positive Anti-drug Antibodies
Serum INS068 concentration
To evaluate PK of INS068
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Change from baseline in scores of DTSQs after 26 weeks of treatment.
Full Information
NCT ID
NCT05702073
First Posted
January 19, 2023
Last Updated
May 5, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05702073
Brief Title
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
October 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INS068
Arm Type
Experimental
Arm Title
IGlar
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
INS068 injection
Intervention Description
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Time Frame
Week 0 to Week 26
Secondary Outcome Measure Information:
Title
Change in FPG(fasting plasma glucose)
Description
Change from baseline in FPG after 26 weeks of treatment
Time Frame
Week 0 to Week 26
Title
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Description
Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks of treatment
Time Frame
Week 0 to Week 26
Title
per-breakfast SMPG
Description
Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment
Time Frame
Week 0 to Week 26
Title
8-point SMPG profiles
Time Frame
Week 0 to Week 26
Title
Average daily Insulin dose
Description
Average daily Insulin dose after 26 weeks of treatment.
Time Frame
Week 0 to Week 26
Title
Proportion of Subjects requiring rescue therapy during treatment
Description
Proportion of subejcts requiring rescue therapy during 26 weeks of treatment
Time Frame
Week 0 to Week 26
Title
Frequency and severity of adverse events
Description
Severity (mild, moderate and severe) is assessed by investigator.
Time Frame
Week 0 to Week26 +14 days follow-up
Title
Incidence and rate of Hypoglycemic events
Description
Incidence and rate of of Hypoglycemic events
Time Frame
Week 0 to Week 26+14 days follow-up
Title
Change in weight
Description
Change from baseline in weight after 26weeks of treatment
Time Frame
Week 0 to Week 26
Title
Anti-drug Antibodies
Description
Number of subjects with Positive Anti-drug Antibodies
Time Frame
Week 0 to Week26 + 14 days follow-up
Title
Serum INS068 concentration
Description
To evaluate PK of INS068
Time Frame
Week 0 to Week 26
Title
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Description
Change from baseline in scores of DTSQs after 26 weeks of treatment.
Time Frame
Week 0 to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miaomiao Shi
Phone
+8618036617171
Email
miaomiao.shi@hengrui.com
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
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