GETGOAL-P

CompletedPhase 3Results posted

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

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

150

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 IDNCT00763815

Org study IDEFC6017

Secondary IDEudraCT: 2007-005884-92

Timeline

Milestones

Study first posted2008-10-01estimated

Results first posted2016-10-11estimated

Last update posted2016-11-28estimated

Study start2008-09 (month precision)

Primary completion2011-06actual (month precision)

Study completion2011-06actual (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 the screening visit, insufficiently controlled with pioglitazone

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 and women of childbearing potential without effective contraceptive method of birth control

•Type 1 diabetes mellitus

•Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening

•If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) for at least 3 months prior to screening visit

•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, or inflammatory bowel disease

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

•Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening

•History of myocardial infarction or stroke within the last 6 months prior to screening

•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 systolic blood pressure or diastolic blood pressure (DBP) >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 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 <100 000/mm^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb); 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 other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl peptidase-4 [DPP-4] inhibitors, insulin) within 3 months prior to the time of screening

•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 study

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

•Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment)

•Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)

•End-stage renal disease defined by a serum creatinine clearance of <15 milliliter per minute (mL/min) (calculated by the Cockcroft and Gault formula) and/or patients on dialysis, if no treatment with metformin

•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 (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 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	0.21	—
Lixisenatide	-0.21	—

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	5.1	—
Lixisenatide	9.2	—

Glycemic / diabetes

7 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	-0.34	—
Lixisenatide	-0.90	—

Least Squares (LS) Mean Difference-0.5695% CI-0.731 – -0.386p<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	-0.32	—
Lixisenatide	-1.16	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
Placebo	-1.01	—
Lixisenatide	-10.36	—

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	26.4	—
Lixisenatide	52.3	—

Secondary/protocol endpoint

Percentage of Patients With 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	10.1	—
Lixisenatide	28.9	—

Secondary/protocol endpoint

Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), % of normal beta cells function	95% CI
Placebo	6.98	—
Lixisenatide	6.72	—

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	11.3	—
Lixisenatide	3.8	—

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 132 weeks

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
PlaceboSymptomatic Hypoglycemia	7	—
Severe Symptomatic Hypoglycemia	0	—
LixisenatideSymptomatic Hypoglycemia	23	—
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

Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Diabetes, obesity & metabolism2013 Nov (month)PMID23627775doi:10.1111/dom.12121via 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.