EAGLE

CompletedPhase 4Results posted

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide

Lead sponsor

Sanofi

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

136

Recruiting sites

—

Enrollment

978

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c ≤12%

Primary endpoint

•HbA1c <7.0% achievement

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 IDNCT01117350

Org study IDLANTU_C_03680

Secondary ID2010-018437-21

Secondary IDU1111-1116-9684UTN

Timeline

Milestones

Study first posted2010-05-05estimated

Results first posted2014-01-29estimated

Last update posted2014-04-11estimated

Study start2010-07 (month precision)

Primary completion2012-10actual (month precision)

Study completion2013-03actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

(comparative period):

•Patients With Type 2 Diabetes diagnosed for at least 1 year,

•Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,

•7.5% < HbA1c <= 12%,

•Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,

•Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary,

•Willingness and ability to comply with the study protocol,

•Signed informed consent obtained prior to any study procedure.

Inclusion criteria (extension period):

•Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)

•Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.

Exclusion criteria

•Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),

•Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry,

•Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),

•Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),

•Lactating women,

•Hospitalized patients (except hospitalization for routine diabetes check-up),

•Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,

•Impaired renal function (creatinine clearance < 60 mL/mn),

•Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range),

•Personal or family history of medullary thyroid carcinoma,

•Multiple endocrine neoplasia syndrome type 2,

•Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),

•Congestive heart failure,

•History of acute pancreatitis,

•Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,

•Alcohol or drug abuse in the past 5 years,

•History of sensitivity to the study drugs or to drugs with a similar chemical structure.

•Night shift worker,

•Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study,

•Participation in a clinical trial (drug or device) within 3 months prior to study entry,

•Refusal or inability to give informed consent to participate in the study,

•Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

Additional exclusion criteria for the extension period:

•Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),

•Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period.

•History of sensitivity to insulin glargine.

Endpoints (34)

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

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Body Weight: Change From Baseline to the End of the Comparative Period

Time frame:baseline (week 0), week 2, week 6, week 12, week 18, week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Insulin Glargine	1.98	—
Liraglutide	-2.99	—

Secondary/registry result

Body Weight: Change From Beginning to End of the Extension Period

Time frame:week 24, week 30, week 36, week 48

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Insulin Glargine (Extension Period)	4.35	—

Secondary/protocol endpoint

Body Weight: Change From Baseline to the End of the Comparative Period

Time frame:baseline (week 0), week 2, week 6, week 12, week 18, week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body Weight: Change From Beginning to End of the Extension Period

Time frame:week 24, week 30, week 36, week 48

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

24 endpoints

Primary/registry result

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period

Time frame:week 12, week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	48.4	—
Liraglutide	45.9	—

Mean Difference (Final Values)2.5495% CI-3.88 – 8.93p0.439Chi-squared

Primary/protocol endpoint

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period

Time frame:week 12, week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period

Time frame:baseline (week -2), week 12, week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	47.1	—
Liraglutide	46.3	—

Secondary/registry result

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period

Time frame:baseline (week -2), week 12, week 24

HbA1c, change

threshold achievement, event

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	4.1	—
Liraglutide	6.6	—

Secondary/registry result

Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period

Time frame:baseline (week -2), week 12, week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent	95% CI
Insulin Glargine	-1.92	—
Liraglutide	-1.81	—

Secondary/registry result

Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period

Time frame:week 24, week 36, week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent	95% CI
Insulin Glargine (Extension Period)	-0.26	—

Secondary/registry result

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period

Time frame:week 36, week 48

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine (Extension Period)	22.7	—

Secondary/registry result

Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period

Time frame:baseline (week 0), week 6, week 12, week 18, week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Insulin Glargine	-65.25	—
Liraglutide	-37.23	—

Secondary/registry result

Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period

Time frame:week 24, week 30, week 36, week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Insulin Glargine (Extension Period)	-44.63	—

Secondary/registry result

Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period

Time frame:baseline (week 0), week 12, week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Insulin GlargineBefore breakfast (N ig = 448 & N l = 409)	-65.92	—
After breakfast (N ig = 440 & N l = 397)	-66.70	—
Before lunch (N ig = 438 & N l = 404)	-50.16	—
After lunch (N ig = 433 & N l = 406)	-43.00	—
Before dinner (N ig = 434 & N l = 400)	-40.84	—
After dinner (N ig = 426 & N l = 396)	-42.6	—
At bedtime (N ig = 380 & N l = 351)	-43.11	—
LiraglutideBefore breakfast (N ig = 448 & N l = 409)	-38.64	—
After breakfast (N ig = 440 & N l = 397)	-55.35	—
Before lunch (N ig = 438 & N l = 404)	-39.13	—
After lunch (N ig = 433 & N l = 406)	-41.82	—
Before dinner (N ig = 434 & N l = 400)	-36.88	—
After dinner (N ig = 426 & N l = 396)	-45.04	—
At bedtime (N ig = 380 & N l = 351)	-44.06	—

Secondary/registry result

Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period

Time frame:week 24, week 36, week 48

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Insulin Glargine (Extension Period)Before breakfast (N=143)	-46.13	—
After breakfast (N=134)	-27.67	—
Before lunch (N=131)	-20.32	—
After lunch (N=134)	-11.50	—
Before dinner (N=133)	-12.56	—
After dinner (N=130)	-2.28	—
At bedtime (N=127)	-14.94	—

Secondary/registry result/low confidence

Daily Dose of Insulin Glargine

Time frame:week 1, week 2, week 6, week 12, week 24

descriptive

Posted result

Group	Value (mean), Unit (U)	95% CI
Insulin GlargineStart of treatment (N=472)	13.39	—
Week 1 (N=470)	17.74	—
Week 2 (N=470)	22.06	—
Week 6 (N=470)	34.67	—
Week 12 (N=463)	44.40	—
Week 18 (N=454)	48.65	—
Week 24 (N=459)	51.67	—
End comparative period (LOCF) (N=474)	51.24	—

Secondary/registry result

Daily Dose of Insulin Glargine Administered During the Extension Period

Time frame:week 30, week 36, week 48

descriptive

Posted result

Group	Value (mean), Unit (U)	95% CI
Insulin Glargine (Extension Period)Start of treatment (N=154)	15.77	—
Week 30 (N=151)	37.49	—
Week 36 (N=150)	46.21	—
Week 48 (N=151)	50.68	—

Secondary/protocol endpoint

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period

Time frame:baseline (week -2), week 12, week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period

Time frame:baseline (week -2), week 12, week 24

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period

Time frame:baseline (week -2), week 12, week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period

Time frame:week 24, week 36, week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period

Time frame:week 36, week 48

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period

Time frame:baseline (week 0), week 6, week 12, week 18, week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period

Time frame:week 24, week 30, week 36, week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period

Time frame:baseline (week 0), week 12, week 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period

Time frame:week 24, week 36, week 48

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Daily Dose of Insulin Glargine

Time frame:week 1, week 2, week 6, week 12, week 24

descriptive, improvement

Secondary/protocol endpoint/low confidence

Daily Dose of Insulin Glargine Administered During the Extension Period

Time frame:week 30, week 36, week 48

descriptive

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Daily Dose of Liraglutide

Time frame:week 1, week 2, week 6, week 12, week 24

descriptive

Posted result

Group	Value (mean), mg	95% CI
LiraglutideStart of treatment (N=470)	0.60	—
Week 1 (N=463)	0.91	—
Week 2 (N=458)	1.49	—
Week 6 (N=444)	1.72	—
Week 12 (N=426)	1.73	—
Week 18 (N=415)	1.74	—
Week 24 (N=431)	1.73	—
End comparative period (LOCF) (N=470)	1.71	—

Secondary/registry result

Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period

Time frame:all across the comparative period (from week 0 to week 24)

Severe hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
Insulin Glarginesymptomatic hypoglycemia	219	—
severe symptomatic hypoglycemia	0	—
Liraglutidesymptomatic hypoglycemia	85	—
severe symptomatic hypoglycemia	2	—

Secondary/registry result

Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period

Time frame:all across the extension period (from week 24 to week 48)

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
Insulin Glargine (Extension Period)symptomatic hypoglycemia	58	—
severe symptomatic hypoglycemia	0	—

Secondary/protocol endpoint

Daily Dose of Liraglutide

Time frame:week 1, week 2, week 6, week 12, week 24

descriptive

Secondary/protocol endpoint

Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period

Time frame:all across the comparative period (from week 0 to week 24)

Severe hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint

Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period

Time frame:all across the extension period (from week 24 to week 48)

Documented hypoglycemia

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.