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Type 2 Diabetes MellitusPhase 4SAFEGUARDNCT04980027

Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

A Phase 4 study testing Insulin glargine (U300) in people with Type 2 Diabetes Mellitus, run by Sanofi at 2 sites in India.

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

Primary Objective: To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs Secondary Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in… 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 (U300)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
2 sitesIndia
Study dates
7 Jun 2021to 23 Dec 2022
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

  • Participants with Type 2 diabetes mellitus
  • Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening.
  • HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.

Who cannot join

  • History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.
  • Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
  • Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.
  • 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

2 sites in 1 country.

India2 sites

  • Investigational site Number 3560003

    Jaipur, 302017

  • Investigational site Number 3560013

    Nashik, 422002

Other trials in India

About this study

Official title: Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs

Primary Objective:

To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs

Secondary Objective:

To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)

Read the detailed description

The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.

Being tested
Insulin glargine (U300)
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 (U300)Drug

    Also called HOE901 Toujeo

    Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous

Study groups in NCT04980027
Study groupRoleWhat they receive
Insuline Glargine (U300) (Gla-300)ExperimentalInsulin glargine (U300) once daily for 24 weeks on top of non-insulin antidiabetic drug. Insulin dose will be adjusted according to the recommended titration algorithm
Receives: Drug: Insulin glargine (U300)

What is being measured

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

  1. Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

    TEAEs including serious adverse events (SAEs) and hypoglycemic episode

    Measured: Baseline to Week 24

Secondary outcomes (11)

  1. Percentage of participants with at least one confirmed hypoglycemia event

    Measured: Baseline to Week 24

  2. Change in HbA1c from Baseline to week 12 and week 24

    Measured: Baseline to Week 12 and Week 24

  3. Percentage of participants reaching HbA1c target of <7%

    Measured: Week 12 and Week 24

  4. Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L)

    Measured: Week 12 and Week 24

  5. Change in fasting plasma glucose (FPG) from Baseline to Week 24

    Measured: Baseline to Week 24

  6. Change in fasting SMBG from Baseline to Week 24

    Measured: Baseline to Week 24

  7. Change in 7-point SMBG profile from Baseline to Week 24

    Measured: Baseline to Week 24

  8. Percentage of participants requiring rescue therapy

    Measured: Week 12 and Week 24

  9. Change in body weight from Baseline to Week 12 and Week 24

    Measured: Baseline to Week 12 and Week 24

  10. Change in insulin dose from Baseline to Week 12 and Week 24

    Measured: Baseline to Week 12 and Week 24

  11. Change in DTSQs scores from Baseline to Week 12 and Week 24

    The Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) is measuring patients' satisfaction with their diabetes treatment.Total treatment satisfaction score range from 0 (no satisfaction) to 36 (improvement in treatment satisfaction)

    Measured: Baseline to Week 12 and Week 24

Timeline

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

  1. First posted28 Jul 2021
  2. Study start7 Jun 2021
  3. Primary completion23 Dec 2022
  4. Study completion23 Dec 2022

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
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04980027
Sponsor's protocol ID
LPS16665
Other IDs
U1111-1255-5143
Acronym
SAFEGUARD
Status last verified
Sep 2025
First submitted
19 Jul 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

  • Mohan V, Sethi B, Jain SM, Sahay R, Ramanathan B, Murthy S, Singh KP, Menon S, Gadekar A, Salvi V, Gandhi K. Multicenter, Phase 4 Clinical Study from India to Evaluate the Safety and Efficacy of Insulin Glargine 300 U/ml in Insulin-Naive People with Type 2 Diabetes Uncontrolled on Oral Anti-hyperglycemic Drugs: SAFEGUARD Study. Diabetes Ther. 2025 Jul;16(7):1367-1383. doi: 10.1007/s13300-025-01736-5. Epub 2025 May 8.

    PubMed 40338497

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine (U300) in people with Type 2 Diabetes Mellitus, run by Sanofi at 2 sites in India.

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 3 inclusion and 5 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 2 sites in India. 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?

Percentage of participants with Treatment Emergent Adverse Events (TEAEs) (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 NCT04980027, 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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