GetGoal-M-Asia

CompletedPhase 3Results posted

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

391

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 IDNCT01169779

Org study IDEFC11321

Secondary IDU1111-1116-8938UTN

Timeline

Milestones

Study first posted2010-07-26estimated

Last update posted2016-10-13estimated

Results first posted2016-10-13estimated

Study start2010-07 (month precision)

Primary completion2011-12actual (month precision)

Study completion2011-12actual (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 1 year before screening visit, insufficiently controlled with metformin alone or metformin with sulfonylurea at the time of the screening visit

Exclusion criteria

•HbA1c <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 metformin not at a stable dose of at least 1.0 gram per day or more than 1.5 gram per day for at least 3 months prior to screening visit

•In case of treatment with sulfonylurea, if the sulfonylurea dosage is less than the maximum effective dose (that is, half of the maximum recommended dose according to local labeling), or is not at a stable (unchanged) dose for at least 3 months prior to screening

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

•History of hypoglycemia unawareness

•Body mass index <=20 kilogram per square meter (kg/m^2)

•Weight change of >5 kg during the 3 months preceding the screening visit

•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease or patients considered by the investigator at high risk for acute pancreatitis (for example, with known history of biliary gallstone[s], or with very high triglyceride level [>=5.65 mmol/L]) at the time of screening

•Personal or family history of medullary thyroid cancer or genetic conditions that predispose to medullary thyroid cancer (for example, multiple endocrine neoplasia syndromes);

•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 systolic blood pressure (SBP) or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively

•Laboratory findings at the time of screening: amylase and/or lipase: >3 times upper limit of normal (ULN); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; calcitonin >20 picogram per milliliter (5.9 picomole per liter) ; and positive test for Hepatitis B surface antigen and/or Hepatitis C antibody

•Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram, 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 attending 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 and sulfonylurea (for example, alpha-glucosidase inhibitor, thiazolidinedione, glucagon-like peptide -1 [GLP-1], receptor agonist, dipeptidyl-peptidase-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 screening;

•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

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

•Allergic reaction to any 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	-1.24	—
Lixisenatide	-1.50	—

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	14.7	—
Lixisenatide	19.7	—

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	-0.47	—
Lixisenatide	-0.83	—

Least squares (LS) mean difference-0.3695% CI-0.551 – -0.162p0.0004ANCOVA

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	-0.21	—
Lixisenatide	-0.69	—

Secondary/protocol endpoint

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo	-1.33	—
Lixisenatide	-5.61	—

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	38.8	—
Lixisenatide	53.0	—

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	18.1	—
Lixisenatide	32.4	—

Secondary/protocol endpoint

Change From Baseline in Glucose Excursion at Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo	-0.79	—
Lixisenatide	-4.78	—

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	6.7	—
Lixisenatide	3.6	—

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
PlaceboSymptomatic hypoglycemia	5	—
Severe symptomatic hypoglycemia	0	—
LixisenatideSymptomatic hypoglycemia	11	—
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

Lixisenatide improves glycemic outcomes of Japanese patients with type 2 diabetes: a meta-analysis.
Diabetology & metabolic syndrome2016 (year)PMID27252787doi:10.1186/s13098-016-0151-7via clinicaltrials gov reference derived + pubmed nct search
Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia).
Diabetes/metabolism research and reviews2014 Nov (month)PMID24639432doi:10.1002/dmrr.2541via 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.