EASE

CompletedPhase 4

A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey

Lead sponsor

Sanofi

Asset

GLP-1 / incretin class catch-all

Subcutaneous

Listed sites

Recruiting sites

—

Enrollment

112

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 8-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02954692

Org study IDGLARGL07921

Secondary IDU1111-1183-8755UTN

Timeline

Milestones

Study first posted2016-11-03estimated

Study start2016-11-30

Primary completion2017-12-22actual

Study completion2017-12-22actual

Last update posted2019-01-14actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adult patients with type 2 diabetes mellitus (≥18 years of age).

•Type 2 diabetes mellitus diagnosis ≥1 year.

•Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).

•Stable antidiabetic treatment for at least 3 months.

•Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).

•Signed informed consent obtained.

Exclusion criteria

•Age <18 years old.

•Type 1 diabetes mellitus.

•Having secondary type 2 diabetes mellitus.

•Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.

•History of hypoglycemia unawareness.

•Known hypersensitivity/intolerance to insulin glargine or any of its excipients.

•Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.

•Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.

•Pregnant or lactating women.

•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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Patient-reported / QoL

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Mean change from baseline in HbA1c

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL

Time frame:At Weeks 12 and 24

threshold achievement, improvement

componentsFasting glucose, change, Severe hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)

Time frame:At Weeks 12 and 24

threshold achievement, improvement

Secondary/protocol endpoint

Duration to reach target pre-breakfast SMBG

Time frame:Baseline, Week 24

time to event, improvement

Secondary/protocol endpoint

Mean change from baseline in HbA1c

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean change from baseline in SMBG

Time frame:Baseline, Weeks 12, and 24

change from baseline, improvement

Secondary/protocol endpoint

Mean change from baseline in fasting plasma glucose (FPG)

Time frame:Baseline, Weeks 12, and 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores

Time frame:Baseline, Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.