To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: INS068 injection
- Registration Number
- NCT05702073
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 423
- 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.
- 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..
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INS068 INS068 injection - IGlar Insulin Glargine -
- Primary Outcome Measures
Name Time Method Change in HbA1c Week 0 to Week 26 Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Incidence and rate of Hypoglycemic events Week 0 to Week 26+14 days follow-up Incidence and rate of of Hypoglycemic events
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.
Anti-drug Antibodies Week 0 to Week26 + 14 days follow-up Number of subjects with Positive Anti-drug Antibodies
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
Change in weight Week 0 to Week 26 Change from baseline in weight after 26weeks of treatment
Serum INS068 concentration Week 0 to Week 26 To evaluate PK of INS068
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.
Trial Locations
- Locations (1)
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China