GetGoal-O

CompletedPhase 3Results posted

Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

350

actual

Study population

Type 2 diabetes

Key I/E criterion

•Age ≥70

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 IDNCT01798706

Org study IDEFC12703

Secondary ID2012-003292-19

Secondary IDU1111-1132-9156UTN

Timeline

Milestones

Study first posted2013-02-26estimated

Results first posted2016-10-14estimated

Last update posted2017-04-18actual

Study start2013-06 (month precision)

Primary completion2015-02actual (month precision)

Study completion2015-02actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen.

•Signed written informed consent.

Exclusion criteria

•At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia).

•At screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides.

•At screening FPG >250 mg/dL (>13.9 mmol/L).

•Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.

•Type 2 diabetes mellitus diagnosed less than 1 year prior to screening.

•Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening.

•Treatment within the 3 months preceding the screening with other anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide >10mg, gliclazide >160mg), meglitinides (except repaglinide >6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population.

•Participants who had been on an approved or an investigational Glucagon-like peptide 1 (GLP-1) medication (exenatide, liraglutide, lixisenatide or others).

•History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening.

•BMI <22 or >40 kg/m^2.

•Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (MNA-SF) score <12 in countries (the judgment of the investigator prevails on questionnaires scores).

•Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by Mini Mental State Examination (MMSE) score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that affected the participant's ability to participate in the study.

•Participant who had a glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease (MDRD) formula <30ml/min/1.73m^2).

•Participant with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment.

•Laboratory findings at the time of screening:

–Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range

–Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times ULN

–Calcitonin >20 pg/mL (5.9 pmol/L).

•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) and not controlled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening.

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

•Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes).

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Endpoints (11)

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

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 24

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lixisenatide	-1.47	—
Placebo	-0.16	—

LS Mean Difference-1.3295% CI-1.862 – -0.769p< 0.0001ANCOVA

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint

Absolute Change in HbA1c From Baseline to 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
Lixisenatide	-0.57	—
Placebo	0.06	—

Least Square (LS) Mean Difference-0.6495% CI-0.81 – -0.464p< 0.0001ANCOVA

Secondary/protocol endpoint

Change in 2-Hour PPG From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-5.12	—
Placebo	-0.07	—

LS Mean Difference-5.0595% CI-5.96 – -4.132p< 0.0001ANCOVA

Secondary/protocol endpoint

Change in Average 7-point SMPG Profiles From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-1.15	—
Placebo	-0.19	—

LS Mean Difference-0.9695% CI-1.39 – -0.527p< 0.0001ANCOVA

Secondary/protocol endpoint

Change in FPG From Baseline to 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
Lixisenatide	-0.3	—
Placebo	0.01	—

LS Mean Difference-0.3195% CI-0.828 – 0.204p0.2347ANCOVA

Secondary/protocol endpoint

Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	2.9	—
Placebo	10.4	—

Secondary/protocol endpoint

Change in Plasma Glucose Excursions From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-4.71	—
Placebo	-0.25	—

Secondary/protocol endpoint/low confidence

Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units	95% CI
Lixisenatide	-2.97	—
Placebo	-1.3	—

Secondary/protocol endpoint

Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia

Time frame:Week 24

threshold achievement, improvement

componentsHbA1c, change, Documented hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	57.6	—
Placebo	21.5	—

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
LixisenatideSymptomatic hypoglycemia	7.4	—
Severe symptomatic hypoglycemia	0.57	—
PlaceboSymptomatic hypoglycemia	5.7	—
Severe symptomatic hypoglycemia	0	—

Secondary/protocol endpoint

Percentage of Participants With Gastrointestinal Disorders

Time frame:Up to Day 171

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	40.3	—
Placebo	20.7	—

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

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
Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial.
Diabetes care2017 Apr (month)PMID28188240doi:10.2337/dc16-2143via 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.