A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

  • STATUS
    Recruiting
  • participants needed
    570
  • sponsor
    Sanofi
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Updated on 2 December 2024
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Summary

This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.

Description

Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.

Details
Condition Type 2 Diabetes Mellitus
Age 18year or above
Treatment Insulin glargine 300 U/ml
Clinical Study IdentifierNCT05002933
SponsorSanofi
Last Modified on2 December 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adult patients (age≥18 years) who diagnosed with type 2 diabetes
Patients who should initiate Insulin glargine U300 treatment following local label and guideline at investigator's discretion, including
insulin naive patients (no current or previous insulin used during the last year prior to screening except for a maximum 10 days in relation to acute illness or surgery, etc.) uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit on stable dose treatment with ≤ 2 OADs (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) within 8 weeks prior to screening, at least one of which must be on maximum tolerated dose, or
patients uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit with other basal insulin, or
patients controlled with other basal insulin but experienced frequent hypoglycemia or with increased hypoglycemia risk at investigator's discretion
Patients who treated with basal insulin must have a stable dose of antidiabetic drugs
(dose change no more than ±20% vs. the dose on screening visit for basal
insulin) within 8 weeks prior to screening

Exclusion Criteria

Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or at baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study
Use of any product containing short or rapid acting insulin in the last 3 months prior to screening (unless used for ≤10 days in relation to hospitalization or an acute illness)
Use of oral anti-diabetic drugs other than those allowed and listed in the inclusion criteria, Glucagon-like peptide-1 (GLP-1) receptor agonists, or any investigational agent (drug, biologic, device) within 3 months prior to screening visit
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening
Known hypersensitivity / intolerance to insulin glargine or any of its excipients
Pregnant or lactating women
Women of childbearing potential with no effective contraceptive method
Participation in another clinical trial
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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