GETGOAL-F1

CompletedPhase 3Results posted

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 in Two Titration Regimens on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

484

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT00763451

Org study IDEFC10743

Secondary ID2008-001002-16

Timeline

Milestones

Study first posted2008-10-01estimated

Last update posted2016-12-14estimated

Results first posted2016-12-14estimated

Study start2008-09 (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 age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 gram/day for at least 3 months prior to screening visit

Exclusion criteria

•HbA1c less than (<) 7% 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

•Treatment with an antidiabetic pharmacological agent other than metformin within the 3 months preceding the screening

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

•Body mass index less than or equal to (<)20 kilogram per square meter (kg/m^2)

•Weight change of more than 5 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; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)

•Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin (for example, sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, rimonabant, exenatide, dipeptidylpeptidase-4 (DPP-IV) inhibitor, insulin) within 3 months prior to the time of screening

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

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

•Any previous treatment with lixisenatide or participation in any previous study with lixisenatide

•Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men

•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; 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 (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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 24

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram	95% CI
Placebo (Combined)	-1.63	—
Lixisenatide (Two-Step Titration)	-2.68	—
Lixisenatide (One-Step Titration)	-2.63	—

Other/protocol endpoint

Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

Time frame:Baseline, Week 24

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	15.2	—
Lixisenatide (Two-Step Titration)	25.8	—
Lixisenatide (One-Step Titration)	19.6	—

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of hemoglobin	95% CI
Placebo (Combined)	-0.42	—
Lixisenatide (Two-Step Titration)	-0.83	—
Lixisenatide (One-Step Titration)	-0.92	—

Least squares (LS) mean difference-0.4195% CI-0.583 – -0.232p<0.0001ANCOVA

Least squares (LS) mean difference-0.4995% CI-0.670 – -0.317p<0.0001ANCOVA

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo (Combined)	0.11	—
Lixisenatide (Two-Step Titration)	-0.56	—
Lixisenatide (One-Step Titration)	-0.53	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	24.1	—
Lixisenatide (Two-Step Titration)	42.1	—
Lixisenatide (One-Step Titration)	47.4	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	7.6	—
Lixisenatide (Two-Step Titration)	20.4	—
Lixisenatide (One-Step Titration)	25.6	—

Secondary/protocol endpoint

Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period

Time frame:Baseline up to Week 24

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	4.4	—
Lixisenatide (Two-Step Titration)	3.1	—
Lixisenatide (One-Step Titration)	1.3	—

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks

Severe hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
Placebo (Combined)Symptomatic hypoglycemia	12	—
Severe symptomatic hypoglycemia	0	—
Lixisenatide (Two-Step Titration)Symptomatic hypoglycemia	12	—
Severe symptomatic hypoglycemia	0	—
Lixisenatide (One-Step Titration)Symptomatic hypoglycemia	6	—
Severe symptomatic hypoglycemia	0	—

Publications (3)

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

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study.
Diabetic medicine : a journal of the British Diabetic Association2014 Apr (month)PMID24236828doi:10.1111/dme.12361via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).
Diabetic medicine : a journal of the British Diabetic Association2014 Feb (month)PMID24117597doi:10.1111/dme.12328via CT.gov reference + pubmed nct search

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.