Fact CheckerSign in

NCT05699408CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 18 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
513 (actual)
First submitted
17 Jan 2023
Start date
31 Mar 2023
Primary completion date
23 Nov 2024
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
NCT number
NCT05699408

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 513
  • From 31 Mar 2023 to the primary completion date, 23 Nov 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 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;

Other illness

  • Known or suspected allergy or intolerance to the investigational medicinal products or related products;
  • Any conditions that the Investigator judges might not besuitable to participate in the trial.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.