GetGoal-Duo1

CompletedPhase 3Results posted

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

140

Recruiting sites

—

Enrollment

446

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 IDNCT00975286

Org study IDEFC10781

Secondary IDEudraCT : 2008-007335-40

Timeline

Milestones

Study first posted2009-09-11estimated

Last update posted2016-10-11estimated

Results first posted2016-10-11estimated

Study start2009-10 (month precision)

Primary completion2011-08actual (month precision)

Study completion2011-08actual (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 insulin glargine and metformin

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

•Metformin not at a stable dose of at least 1.5 gram per day for at least 3 months prior to the screening visit

•Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea (SU) and TZDs (for example, alpha glucosidase inhibitor, other glucagon like peptide-1 [GLP-1] receptor agonists, dipeptidyl peptidase-IV [DPP-IV] inhibitors, insulin etc.) within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit

•History of hypoglycemia unawareness

•Body Mass Index (BMI) less than or equal to (<=) 20 kilogram per square meter (kg/m^2)

•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)

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

•Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion 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

•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 such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy 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 or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110 mmHg, respectively

•Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase >3 times upper limit of the normal (ULN) laboratory range; 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 and/or Hepatitis C antibody, positive serum pregnancy test in females of childbearing potential; and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter [pmol/L])

•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 being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)

•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 screening

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

•History of hypersensitivity to insulin glargine or to any of the excipients

•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

•Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)

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

•Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was >140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is <7% or >9%, amylase and/or lipase > 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG >240 mg/dL [13.3 mmol/L]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase

Endpoints (13)

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

Patient-reported / QoL

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	1.16	—
Lixisenatide	0.28	—

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	3.2	—
Lixisenatide	5.1	—

Glycemic / diabetes

9 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	-0.40	—
Lixisenatide	-0.71	—

[Least squares (LS) mean difference-0.3295% CI-0.463 – -0.171p<0.0001ANCOVA

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	0.08	—
Lixisenatide	-3.09	—

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	-0.33	—
Lixisenatide	-3.42	—

Secondary/protocol endpoint

Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile 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	-0.08	—
Lixisenatide	-0.47	—

Secondary/protocol endpoint

Change From Baseline in Average Insulin Glargine Daily Dose at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units per day	95% CI
Placebo	5.34	—
Lixisenatide	3.10	—

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	0.46	—
Lixisenatide	0.34	—

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	38.5	—
Lixisenatide	56.3	—

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	16.3	—
Lixisenatide	32.1	—

Secondary/protocol endpoint

Percentage of Patients Requiring Rescue Therapy During the Double-blind Period

Time frame:Baseline up to Week 24

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	0.4	—
Lixisenatide	0.4	—

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24

Time frame:Baseline, Week 24

PGI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
Placebo	0.65	—
Lixisenatide	0.88	—

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	30	—
Severe symptomatic hypoglycemia	0	—
LixisenatideSymptomatic hypoglycemia	50	—
Severe symptomatic hypoglycemia	1	—

Publications (6)

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

Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2023 Apr (month)PMID36809495doi:10.1007/s13300-023-01369-6via clinicaltrials gov reference derived + pubmed nct search
Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.
Clinical diabetes and endocrinology2020 (year)PMID31956422doi:10.1186/s40842-019-0088-5via clinicaltrials gov reference derived + pubmed nct search
Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes.
Diabetes, obesity & metabolism2018 Dec (month)PMID29974618doi:10.1111/dom.13462via clinicaltrials gov reference derived + pubmed nct search
Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis.
Journal of diabetes and its complications2014 Nov-Dec (year)PMID25130920doi:10.1016/j.jdiacomp.2014.07.007via clinicaltrials gov reference derived + pubmed nct search
Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1).
Diabetes care2013 Sep (month)PMID23564915doi:10.2337/dc12-2462via CT.gov reference + pubmed nct search
Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L).
Diabetes care2013 Sep (month)PMID23628617doi:10.2337/dc12-2454via clinicaltrials gov reference derived + 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.