GetGoal-Duo-2

CompletedPhase 3Results posted

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

199

Recruiting sites

—

Enrollment

894

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)

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 IDNCT01768559

Org study IDEFC12626

Secondary ID2012-004096-38

Secondary IDU1111-1131-4936UTN

Timeline

Milestones

Study first posted2013-01-15estimated

Last update posted2017-01-04estimated

Results first posted2017-01-04estimated

Study start2013-01 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (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

•Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).

•Participants treated with basal insulin for at least 6 months.

•Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.

•Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria

•At screening: age < legal age of majority.

•At screening, HbA1c: <7.5% and >10.0% for participants treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.

•Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.

•Type 1 diabetes mellitus.

•Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.

•Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.

•Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.

•At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2.

•Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.

•Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.

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

•At screening resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.

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

•Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.

•Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.

•At screening, amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN).

•At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.

•At screening calcitonin ≥20 pg/ml (5.9 pmol/L).

Exclusion Criteria for randomization at the end of the screening period before randomization:

•HbA1c <7.0% or >9.0%.

•7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).

•Amylase and/or lipase >3 times ULN.

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

Endpoints (15)

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

Primary/protocol endpoint

Change in Body Weight From Baseline to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lixisenatide	-0.63	—
Insulin Glulisine QD	1.03	—
Insulin Glulisine TID	1.37	—

LS Mean Difference-1.9995% CI-2.593 – -1.396p< 0.0001ANCOVA

Secondary/protocol endpoint

Percentage of Participants With no Weight Gain at Week 26

Time frame:Week 26

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	64.7	—
Insulin Glulisine QD	36.6	—
Insulin Glulisine TID	30.5	—

Glycemic / diabetes

12 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of hemoglobin	95% CI
Lixisenatide	-0.63	—
Insulin Glulisine QD	-0.58	—
Insulin Glulisine TID	-0.84	—

Least Square (LS) Mean Difference-0.0595% CI-0.17 – 0.064ANCOVA

LS Mean Difference0.2195% CI0.095 – 0.328ANCOVA

Secondary/protocol endpoint

Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
LixisenatideHbA1c ≤6.5%	20.5	—
HbA1c <7.0%	42.1	—
Insulin Glulisine QDHbA1c ≤6.5%	17.8	—
HbA1c <7.0%	38.4	—
Insulin Glulisine TIDHbA1c ≤6.5%	30.8	—
HbA1c <7.0%	49.2	—

Secondary/protocol endpoint

Change in Average 7-point SMPG Profiles From Baseline to Week 26

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-0.784	—
Insulin Glulisine QD	-0.782	—
Insulin Glulisine TID	-1.053	—

Secondary/protocol endpoint

Change in FPG From Baseline to Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-0.23	—
Insulin Glulisine QD	-0.21	—
Insulin Glulisine TID	-0.06	—

Secondary/protocol endpoint

Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Lixisenatide	-3.93	—
Insulin Glulisine QD	-1.62	—
Insulin Glulisine TID	-1.87	—

Secondary/protocol endpoint

Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Lixisenatide	-3.42	—
Insulin Glulisine QD	-1.59	—
Insulin Glulisine TID	-1.56	—

Secondary/protocol endpoint

Change in Insulin Glargine Dose From Baseline to Week 26

Time frame:Baseline, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), U	95% CI
Lixisenatide	0.7	—
Insulin Glulisine QD	-0.06	—
Insulin Glulisine TID	-3.13	—

Secondary/protocol endpoint/low confidence

Insulin Glulisine Dose at Week 26

Time frame:Week 26

descriptive

Posted result

Group	Value (mean), U	95% CI
Insulin Glulisine QD	9.97	—
Insulin Glulisine TID	20.24	—

Secondary/protocol endpoint/low confidence

Total Insulin Dose at Week 26

Time frame:Week 26

descriptive

Posted result

Group	Value (mean), U	95% CI
Insulin Glulisine QD	73.61	—
Insulin Glulisine TID	81.05	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	29.4	—
Insulin Glulisine QD	24.2	—
Insulin Glulisine TID	26.1	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	31.2	—
Insulin Glulisine QD	16.7	—
Insulin Glulisine TID	17.6	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	22.2	—
Insulin Glulisine QD	9.2	—
Insulin Glulisine TID	10.8	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
LixisenatideDocumented symptomatic hypoglycemia	31.5	—
Severe symptomatic hypoglycemia	0	—
Insulin Glulisine QDDocumented symptomatic hypoglycemia	37.5	—
Severe symptomatic hypoglycemia	0.7	—
Insulin Glulisine TIDDocumented symptomatic hypoglycemia	44.6	—
Severe symptomatic hypoglycemia	0	—

Publications (4)

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 iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Jan (month)PMID31848983doi:10.1007/s13300-019-00735-7via clinicaltrials gov reference derived + pubmed nct search
Clinical implications of prolonged hyperglycaemia before basal insulin initiation in type 2 diabetes patients: An electronic medical record database analysis.
Endocrinology, diabetes & metabolism2019 Jul (month)PMID31294079doi:10.1002/edm2.61via 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
Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Diabetes care2016 Aug (month)PMID27222510doi:10.2337/dc16-0014via 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.