GETGOAL-MONO

CompletedPhase 3Results posted

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

361

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 IDNCT00688701

Org study IDEFC6018

Secondary IDEudraCT 2007-005887-29

Timeline

Milestones

Study first posted2008-06-03estimated

Last update posted2016-12-12estimated

Results first posted2016-12-12estimated

Study start2008-05 (month precision)

Primary completion2009-12actual (month precision)

Study completion2009-12actual (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 2 months at the time of the screening visit, not treated with any antidiabetic agent

Exclusion criteria

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

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

•Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control

•Type 1 diabetes mellitus

•Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study

•Fasting plasma glucose 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 previous 3 months

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

•History of metabolic acidosis, including diabetic ketoacidosis within the previous year

•Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the previous 3 months

•History of myocardial infarction, stroke, or heart failure requiring hospitalization within the previous 6 months

•Known history of drug or alcohol abuse within the previous 6 months

•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 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, alanine aminotransferase or alkaline phosphatase: >2 times the upper limit of the normal (ULN) laboratory range; amylase and/or lipase: >3 ULN; total bilirubin: >1.5 ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter (g/dL) and/or neutrophils <1,500 per cubic mm (mm^3) and/or platelets <100,000/mm^3; positive test for Hepatitis B surface antigen and/or hepatitis C antibody

•Any clinically significant abnormality identified by physical examination, laboratory tests, electrocardiogram or vital sign at the time of screening that in the judgment of the investigator or any sub investigator precludes safe completion of the study or hinders the efficacy assessment

•Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason

•Use of systemic glucocorticoids (excluding topical application or inhaled forms) within the previous 3 months

•Participation in any previous study with lixisenatide

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

•End-stage renal disease as defined by a calculated serum creatinine clearance of <15 milliliter/minute 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 the previous 6 months

•History of allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past 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: more than 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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 12

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram	95% CI
Placebo (Combined)	-1.98	—
Lixisenatide (Two-Step Titration)	-1.96	—
Lixisenatide (One-Step Titration)	-1.92	—

Other/protocol endpoint

Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12

Time frame:Baseline, Week 12

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	17.2	—
Lixisenatide (Two-Step Titration)	16.2	—
Lixisenatide (One-Step Titration)	18.3	—

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of hemoglobin	95% CI
Placebo (Combined)	-0.19	—
Lixisenatide (Two-Step Titration)	-0.73	—
Lixisenatide (One-Step Titration)	-0.85	—

Least squares (LS) mean difference-0.5495% CI-0.785 – -0.300p<0.0001ANCOVA

LS mean difference-0.6695% CI-0.903 – -0.423p<0.0001ANCOVA

Secondary/protocol endpoint

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12

Time frame:Baseline, Week 12

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo (Combined)	-0.65	—
Lixisenatide (Two-Step Titration)	-4.51	—
Lixisenatide (One-Step Titration)	-5.47	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo (Combined)	0.19	—
Lixisenatide (Two-Step Titration)	-0.68	—
Lixisenatide (One-Step Titration)	-0.89	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12

Time frame:Week 12

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	26.8	—
Lixisenatide (Two-Step Titration)	52.2	—
Lixisenatide (One-Step Titration)	46.5	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12

Time frame:Week 12

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	12.5	—
Lixisenatide (Two-Step Titration)	31.9	—
Lixisenatide (One-Step Titration)	25.4	—

Secondary/protocol endpoint

Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period

Time frame:Baseline up to Week 12

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo (Combined)	2.5	—
Lixisenatide (Two-Step Titration)	1.7	—
Lixisenatide (One-Step Titration)	0.8	—

Other/protocol endpoint

Change From Baseline in Glucose Excursion at Week 12

Time frame:Baseline, Week 12

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo (Combined)	-0.67	—
Lixisenatide (Two-Step Titration)	-3.77	—
Lixisenatide (One-Step Titration)	-4.36	—

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

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
Placebo (Combined)Symptomatic hypoglycemia	2	—
Severe symptomatic hypoglycemia	0	—
Lixisenatide (Two-Step Titration)Symptomatic hypoglycemia	3	—
Severe symptomatic hypoglycemia	0	—
Lixisenatide (One-Step Titration)Symptomatic hypoglycemia	1	—
Severe symptomatic hypoglycemia	0	—

Publications (2)

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

Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2024 May 21PMID38770818doi:10.1002/14651858.CD015588.pub2via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).
Diabetes care2012 Jun (month)PMID22432104doi:10.2337/dc11-1935via 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.