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Completed

NCT Number: NCT05702073

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, 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;
  • 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..

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

    Change from baseline in FPG after 26 weeks of treatment

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

    Time frame: Week 0 to Week 26

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

  3. per-breakfast SMPG

    Time frame: Week 0 to Week 26

    Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment

  4. 8-point SMPG profiles

    Time frame: Week 0 to Week 26

  5. Average daily Insulin dose

    Time frame: Week 0 to Week 26

    Average daily Insulin dose after 26 weeks of treatment.

  6. Proportion of Subjects requiring rescue therapy during treatment

    Time frame: Week 0 to Week 26

    Proportion of subejcts requiring rescue therapy during 26 weeks of treatment

  7. Frequency and severity of adverse events

    Time frame: Week 0 to Week26 +14 days follow-up

    Severity (mild, moderate and severe) is assessed by investigator.

  8. Incidence and rate of Hypoglycemic events

    Time frame: Week 0 to Week 26+14 days follow-up

    Incidence and rate of of Hypoglycemic events

  9. Change in weight

    Time frame: Week 0 to Week 26

    Change from baseline in weight after 26weeks of treatment

  10. Anti-drug Antibodies

    Time frame: Week 0 to Week26 + 14 days follow-up

    Number of subjects with Positive Anti-drug Antibodies

  11. Serum INS068 concentration

    Time frame: Week 0 to Week 26

    To evaluate PK of INS068

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

    Time frame: Week 0 to Week 26

    Change from baseline in scores of DTSQs after 26 weeks of treatment.

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 Basal Insulin

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Mar 13, 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.

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