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NCT05699408 | Active, not recruiting | Type 2 Diabetes

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
Sponsor:

Jiangsu H鞥R UI medicine co., Ltd.

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.

Condition or disease

Type 2 Diabetes

Intervention/treatment

INS068 injection

Insulin Glargine

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 513 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 Oral Antidiabetic Drugs
Actual Study Start Date : March 31, 2023
Estimated Primary Completion Date : September 23, 2025
Estimated Study Completion Date : September 23, 2025
Arm Intervention/treatment

Experimental: INS068 injection

Drug: INS068 injection

Active Comparator: Insulin Glargine

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；
  • 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.
  • Glycated hemoglobin was 7.0%~11.0% (both inclusive) at screening
Exclusion Criteria
  • Known or suspected allergy or intolerance to the investigational medicinal products or related products；
  • Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；
  • Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；
  • Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.
  • 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;
  • 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;
  • Any conditions that the Investigator judges might not besuitable to participate in the trial.
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

Location Details

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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

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

Not yet recruiting

China, Beijing

Peking University People's Hospital

Beijing, Beijing, China, 100044