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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: INS068 injection
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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..

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |