Skip to main content
OpenTrials
Completed

NCT Number: NCT05699408

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INS068 injection

Drug

INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial

insulin glargine

Drug

Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial

Primary outcomes

  1. Change in HbA1c

    Time frame: Week 0 to Week 26

    Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment

Secondary outcomes

  1. Change in FPG(fasting plasma glucose)

    Time frame: Week 0 to Week 26, Week 0 to Week 52

    Change from baseline in FPG after 26 weeks and 52 weeks of treatment

  2. Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%

    Time frame: Week 0 to Week 26 、Week 0 to Week 52

    Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks and 52 weeks of treatment

  3. Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period

    Time frame: Week 0 to Week 26, Week 0 to Week 52

  4. Change in HbA1c

    Time frame: Week 0 to Week 52

  5. per-breakfast SMPG

    Time frame: Week 0 to Week 26 、Week 0 to Week 52

  6. 8-point SMPG profiles

    Time frame: Week 0 to Week 26 、Week 0 to Week 52

  7. Average daily Insulin dose

    Time frame: Week 0 to Week 26 、Week 0 to Week 52

  8. Proportion of Subjects requiring rescue therapy during treatment

    Time frame: Week 0 to Week 26 、Week 0 to Week 52

  9. Frequency and severity of adverse events

    Time frame: Week 0 to Week 52 + 14 days follow-up

  10. Incidence and rate of Hypoglycemic events

    Time frame: Week 0 to Week 52 + 14 days follow-up

  11. Change in weight

    Time frame: Week 0 to Week 26、Week 0 to Week 52

  12. Anti-drug Antibodies

    Time frame: Week 0 to Week 52 + 14 days follow-up

  13. Serum INS068 concentration

    Time frame: Week 0 to Week 52

  14. Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)

    Time frame: Week 0 to Week 26 、Week 0 to Week 52

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.