Clinical trial NCT05702073: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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..

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 0 to Week 26
Secondary outcomes:
measure: Change in FPG(fasting plasma glucose)
timeFrame: Week 0 to Week 26
measure: Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
timeFrame: Week 0 to Week 26
measure: per-breakfast SMPG
timeFrame: Week 0 to Week 26
measure: 8-point SMPG profiles
timeFrame: Week 0 to Week 26
measure: Average daily Insulin dose
timeFrame: Week 0 to Week 26
measure: Proportion of Subjects requiring rescue therapy during treatment
timeFrame: Week 0 to Week 26
measure: Frequency and severity of adverse events
timeFrame: Week 0 to Week26 +14 days follow-up
measure: Incidence and rate of Hypoglycemic events
timeFrame: Week 0 to Week 26+14 days follow-up
measure: Change in weight
timeFrame: Week 0 to Week 26
measure: Anti-drug Antibodies
timeFrame: Week 0 to Week26 + 14 days follow-up
measure: Serum INS068 concentration
timeFrame: Week 0 to Week 26
measure: Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
timeFrame: Week 0 to Week 26
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References: