GETGOAL-MONO

CompletedPhase 3Results posted

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)

A Randomized, Open Label, Parallel-group (One-step Titration and Two-step Titration), Multicenter 52-Week Study Followed by a 24-Week Extension Assessing the Safety and Tolerability of AVE0010 Monotherapy in Patients With Type 2 Diabetes

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT00905255

Org study IDLTS10888

Timeline

Milestones

Study first posted2009-05-20estimated

Last update posted2016-12-21estimated

Results first posted2016-12-21estimated

Study start2009-05 (month precision)

Primary completion2011-01actual (month precision)

Study completion2011-01actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus, diagnosed for at least 2 months at the time of screening visit, not treated by an antidiabetic agent in the 3 months before screening, except treatment with sulfonylureas or alpha-glucosidase inhibitors at a stable dose. In this case the oral antidiabetic treatment must be discontinued before starting single-blind run-in phase

Exclusion criteria

•HbA1c less than (<) 7 percent (%) or greater than (>) 10% at screening

•At the time of screening age <legal age of majority

•Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method

•Type 1 diabetes mellitus

•Type 2 diabetes treated by an antidiabetic pharmacological agent (except sulfonylurea or alpha-glucosidase inhibitors at a stable dose) within the 3 months preceding the screening. Insulin use is accepted if it is not within 3 months prior to screening visit and only for the following reasons:

a)Prior insulin use for management of gestational diabetes;

b)Short-term (less than or equal to [<=] 1 month) insulin use to maintain glycemic control for hospitalization, medical procedures, or intervention

•FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L])

•Weight change of more than 5 kilogram (kg) during the 3 months preceding the screening visit

•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease

•History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening

•Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening

•Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization

•Known history of drug or alcohol abuse within 6 months prior to the time of screening

•Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period

•Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 millimeter of mercury (mmHg) or >95 mmHg, respectively

•Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): >2 times upper limit of the normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100000/mm^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb) and positive serum pregnancy test in females of childbearing potential

•Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG) or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator precludes safe completion of the study or constrains efficacy assessment

•Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol)

•Patient is an investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol

•Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening

•Use of any investigational drug within 3 months prior to screening

•Participation in a previous study with lixisenatide

•End-stage renal disease as defined by a serum creatinine clearance of <15 milliliter/minute (calculated by the Cockcroft and Gault formula) and/or patients on dialysis

•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening

•Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example, exenatide, liraglutide) or to metacresol

•Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal (patient not willing to continue or failed to return); lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the Investigator

Endpoints (10)

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

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight for All Patients at Week 52 and 76

Time frame:Baseline, Week 52, 76

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilogram	95% CI
Lixisenatide (Combined)Week 52 (n=47, observed cases)	-1.67	—
Week 76 (n=33, observed cases)	-1.58	—

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76

Time frame:Baseline, Week 52, 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of hemoglobin	95% CI
Lixisenatide (Combined)Week 52 (n=47, observed cases)	-0.83	—
Week 76 (n=33, observed cases)	-0.72	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76

Time frame:Week 52, 76

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide (Combined)Week 52 (n=47, observed cases)	40.4	—
Week 76 (n=33, observed cases)	27.3	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76

Time frame:Week 52, 76

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide (Combined)Week 52 (n=47, observed cases)	14.9	—
Week 76 (n=33, observed cases)	18.2	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76

Time frame:Baseline, Week 52, 76

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Lixisenatide (Combined)Week 52 (n=47, observed cases)	-0.96	—
Week 76 (n=33, observed cases)	-0.46	—

Other/protocol endpoint

Percentage of Patients Requiring Rescue Therapy

Time frame:Baseline up to Week 52, Baseline up to Week 76

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide (Combined)Baseline up to Week 52	17.4	—
Baseline up to Week 76	23.2	—

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring

Time frame:First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal

Treatment-emergent AEs (any)

descriptive

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide (Two-step Titration)Any TEAE	81.8	—
Any Serious TEAE	6.1	—
Any TEAE Leading to Death	0	—
Any TEAE Leading to Treatment Discontinuation	9.1	—
Lixisenatide (One-step Titration)Any TEAE	88.9	—
Any Serious TEAE	0	—
Any TEAE Leading to Death	0	—
Any TEAE Leading to Treatment Discontinuation	11.1	—

Secondary/protocol endpoint

Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring

Time frame:First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal

Treatment-emergent AEs (any)

descriptive

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide (Combined)Any TEAE	91.3	—
Any Serious TEAE	4.3	—
Any TEAE Leading to Death	0	—
Any TEAE Leading to Treatment Discontinuation	14.5	—

Other/protocol endpoint

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period

Time frame:First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
Lixisenatide (Two-step Titration)Symptomatic Hypoglycemia	2	—
Severe Symptomatic Hypoglycemia	0	—
Lixisenatide (One-step Titration)Symptomatic Hypoglycemia	1	—
Severe Symptomatic Hypoglycemia	0	—

Other/protocol endpoint

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period

Time frame:First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
Lixisenatide (Combined)Symptomatic hypoglycemia	5	—
Severe symptomatic hypoglycemia	0	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan.
Journal of diabetes and its complications2015 Nov-Dec (year)PMID26342556doi:10.1016/j.jdiacomp.2015.07.003via CT.gov reference

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.