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New insulin study aims to tame type 2 diabetes when pills fall short

NCT ID NCT04980027

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a long-acting insulin called glargine (brand name Toujeo) in 228 adults with type 2 diabetes whose blood sugar was still too high despite taking oral diabetes medications. The main goal was to see how safe the insulin was, including any low blood sugar episodes. Researchers also checked whether it helped lower blood sugar levels and improved patients' satisfaction with their treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
insulin glargine (Toujeo)
What this could lead to
If successful, this could confirm that starting insulin glargine is a safe and effective option for people with type 2 diabetes who need better blood sugar control.
What could go wrong
This is a single-arm, phase 4 study with no comparison group, so results are less definitive. Side effects like low blood sugar (hypoglycemia) are possible with insulin therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

228 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * 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. Exclusion criteria: * 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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Investigational site Number 3560003

    Jaipur, 302017, India

  • Investigational site Number 3560013

    Nashik, 422002, India

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