Clinical trial NCT05699408: To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
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 Oral Antidiabetic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 513
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 is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 2 diabetes ≥ 6 months；
2. Stable daily dose(s) for ≥8 weeks prior to screening of any of the following anti-diabetic drug(s) or combination regimen(s): 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any of the following oral antidiabetic drugs with dose ≥half of the maximum approved dose according to local label or maximum tolerated): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones and Alpha-glucosidase inhibitors.
3. Glycated hemoglobin was 7.0%\~11.0% (both inclusive) at screening

Exclusion Criteria:

1. Known or suspected allergy or intolerance to the investigational medicinal products or related products；
2. Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；
3. Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；
4. Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.
5. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 1 month or 5 half-lives, 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;
7. Any conditions that the Investigator judges might not besuitable 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, Week 0 to Week 52
measure: Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
timeFrame: Week 0 to Week 26 、Week 0 to Week 52
measure: Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period
timeFrame: Week 0 to Week 26, Week 0 to Week 52
measure: Change in HbA1c
timeFrame: Week 0 to Week 52
measure: per-breakfast SMPG
timeFrame: Week 0 to Week 26 、Week 0 to Week 52
measure: 8-point SMPG profiles
timeFrame: Week 0 to Week 26 、Week 0 to Week 52
measure: Average daily Insulin dose
timeFrame: Week 0 to Week 26 、Week 0 to Week 52
measure: Proportion of Subjects requiring rescue therapy during treatment
timeFrame: Week 0 to Week 26 、Week 0 to Week 52
measure: Frequency and severity of adverse events
timeFrame: Week 0 to Week 52 + 14 days follow-up
measure: Incidence and rate of Hypoglycemic events
timeFrame: Week 0 to Week 52 + 14 days follow-up
measure: Change in weight
timeFrame: Week 0 to Week 26、Week 0 to Week 52
measure: Anti-drug Antibodies
timeFrame: Week 0 to Week 52 + 14 days follow-up
measure: Serum INS068 concentration
timeFrame: Week 0 to Week 52
measure: Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
timeFrame: Week 0 to Week 26 、Week 0 to Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: