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Type 2 Diabetes MellitusPhase 4INITIATIONNCT05002933

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

A Phase 4 study testing Insulin glargine 300 U/ml in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin glargine 300 U/ml
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
1 siteChina
Study dates
20 May 2021to 24 Feb 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Investigational Sites

    China

Other trials in China

About this study

Official title: A 6-month, Multicenter, Prospective, Single-arm, Open-label, Phase IV Study Evaluating the Clinical Efficacy and Safety of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

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.

Read the detailed 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.

Being tested
Insulin glargine 300 U/ml
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine 300 U/mlDrug

    Also called HOE901 Toujeo

    Solution for injection Subcutaneous injection

Study groups in NCT05002933
Study groupRoleWhat they receive
Insulin glargine 300 U/mlExperimentalInsulin 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
Receives: Drug: Insulin glargine 300 U/ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in HbA1c from baseline to week 24

    Measured: Baseline to Week 24

Secondary outcomes (11)

  1. Mean change in HbA1c from baseline to week 12 and week 36

    Measured: Baseline to Week 12 and 36

  2. Percentage of participants achieving HbA1c target <7%

    Measured: at Week 12, 24 and 36

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

    Measured: at Week 12 and 24

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

    Measured: Baseline to Week 12, 24 and 36

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

    Measured: Baseline to Week 12 and 24

  6. Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24

    Measured: Baseline to Week 12 and 24

  7. Mean change in Insulin glargine U300 dose from baseline to week 12, 24 and 36

    Measured: Baseline to Week 12, 24 and 36

  8. Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36

    Measured: Baseline to Week 12, 24 and 36

  9. Number of hypoglycemic events per patient-year

    Measured: Baseline to Week 12, 24 and 36

  10. Number of participants with adverse events

    Measured: Baseline to Week 24 and 36

  11. Mean change in body weight from baseline to Week 12 and Week 24

    Measured: Baseline to Week 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start20 May 2021
  3. Primary completion24 Feb 2023
  4. Study completion24 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002933
Sponsor's protocol ID
LPS16585
Other IDs
U1111-1251-4484
Acronym
INITIATION
Status last verified
Sep 2025
First submitted
5 Aug 2021
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Chen L, Wen B, Liu H, Wu H, Duan B, Shu H, Zhang Q, Wu X, Li M, Han Y, Kang L, Zhang M. Efficacy and safety of insulin glargine 300 U/mL in people with type 2 diabetes in China: The INITIATION study. Diabetes Obes Metab. 2024 Oct;26(10):4571-4582. doi: 10.1111/dom.15814. Epub 2024 Jul 29.

    PubMed 39075925

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine 300 U/ml in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in HbA1c from baseline to week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05002933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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