Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGINS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
DRUGInsulin Glargine
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0 to Week 26 | Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in FPG(fasting plasma glucose) | Week 0 to Week 26 | Change from baseline in FPG after 26 weeks of treatment |
| 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. |
| Frequency and severity of adverse events | Week 0 to Week26 +14 days follow-up | Severity (mild, moderate and severe) is assessed by investigator. |
Countries
China
Outcome results
None listed