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

NCT05002933 | Completed Phase 4

• 2 other identifiers: LPS16585U1111-1251-4484
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean change in HbA1c from baseline to week 24

  Baseline to Week 24

Secondary Outcomes (11)

• Mean change in HbA1c from baseline to week 12 and week 36

  Baseline to Week 12 and 36

• Percentage of participants achieving HbA1c target <7%

  at Week 12, 24 and 36

• Percentage of participants achieving HbA1c target <7% without hypoglycemic events

  at Week 12 and 24

• Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36

  Baseline to Week 12, 24 and 36

• Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24

  Baseline to Week 12 and 24

Study Arms (1)

Insulin glargine 300 U/ml

EXPERIMENTAL

Insulin glargine 300 U/ml once daily for 24 weeks. Participants may continue for an additional 12 week extension period or switch to other anti-diabetic treatment, insulin dose will be adjusted according to the recommended dose titration algorithm

Drug: Insulin glargine 300 U/ml

Interventions

Insulin glargine 300 U/ml DRUG

Solution for injection Subcutaneous injection

Also known as: HOE901 Toujeo

Insulin glargine 300 U/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Sites

China, China

Location

Related Links

• LPS16585 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 12, 2021
• Study Start: May 20, 2021
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)