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

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 Identifier	NCT05002933
Sponsor	Sanofi
Last Modified on	2 December 2024

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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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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

Summary

Description

Details

How to participate?

Trial Transparency email recommended (Toll free number for US & Canada)

Investigational Sites

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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

Summary

Description

Details

How to participate?

Trial Transparency email recommended (Toll free number for US & Canada)

Investigational Sites

Similar trials to consider

Not finding what you're looking for?

Sign up as a volunteer to stay informed

Study AnnotationsStudy Notes

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Study Definition

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