NCT05702073CompletedPhase 3
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 423 (actual)
- First submitted
- 19 Jan 2023
- Start date
- 31 Mar 2023
- Primary completion date
- 11 Jun 2024
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05702073
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 423
- From 31 Mar 2023 to the primary completion date, 11 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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..
Other illness
- Known or suspected allergy or intolerance to investigational medicinal products or related products.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.