To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: INS068
|
Drug: INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
|
| Active Comparator: IGlar
|
Drug: Insulin Glargine
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [Week 0 to Week 26]
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Secondary Outcome Measures
- Change in FPG(fasting plasma glucose) [Week 0 to Week 26]
Change from baseline in FPG after 26 weeks of treatment
- Proportion of Subjects with HbA1c<7% and HbA1c≤6.5% [Week 0 to Week 26]
Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks of treatment
- per-breakfast SMPG [Week 0 to Week 26]
Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment
- 8-point SMPG profiles [Week 0 to Week 26]
- Average daily Insulin dose [Week 0 to Week 26]
Average daily Insulin dose after 26 weeks of treatment.
- Proportion of Subjects requiring rescue therapy during treatment [Week 0 to Week 26]
Proportion of subejcts requiring rescue therapy during 26 weeks of treatment
- Frequency and severity of adverse events [Week 0 to Week26 +14 days follow-up]
Severity (mild, moderate and severe) is assessed by investigator.
- Incidence and rate of Hypoglycemic events [Week 0 to Week 26+14 days follow-up]
Incidence and rate of of Hypoglycemic events
- Change in weight [Week 0 to Week 26]
Change from baseline in weight after 26weeks of treatment
- Anti-drug Antibodies [Week 0 to Week26 + 14 days follow-up]
Number of subjects with Positive Anti-drug Antibodies
- Serum INS068 concentration [Week 0 to Week 26]
To evaluate PK of INS068
- Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs) [Week 0 to Week 26]
Change from baseline in scores of DTSQs after 26 weeks of treatment.
Eligibility Criteria
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.
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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..
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INS068-301