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NCT05702073 | Recruiting | Type 2 Diabetes Mellitus

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
Sponsor:

Jiangsu H鞥R UI 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.

Condition or disease

Type 2 Diabetes Mellitus

Intervention/treatment

INS068 injection

Insulin Glargine

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 400 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : March 31, 2023
Estimated Primary Completion Date : October 23, 2024
Estimated Study Completion Date : October 23, 2024
Arm Intervention/treatment

Experimental: INS068

Drug: INS068 injection

Active Comparator: IGs

Drug: Insulin Glargine
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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..
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.

Location Details

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To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

China, Shanghai

Zhongshan Hospital

Shanghai, Shanghai, China, 200032