LixiBIT

CompletedPhase 3Results posted

Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin

Feasibility of Once-daily Administered GLP-1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin in Patients With Type-2 Diabetes Mellitus Not Achieving Therapeutic Targets With Premixed Insulin

Lead sponsor

Medical University of Vienna

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT02168491

Org study IDLixiBIT_V3

Secondary ID2013-005334-37

Timeline

Milestones

Study first posted2014-06-20estimated

Results first posted2017-04-04actual

Last update posted2017-05-09actual

Study start2014-11 (month precision)

Primary completion2015-07actual (month precision)

Study completion2015-08actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 18 - 70a

•Subjects understand study related activities and give written informed concent

•HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections)

Exclusion criteria

•Females of child-bearing age

•History of hypoglycemia unawareness

•Gastrointestinal disease associated with prolonged nausea and vomiting

•Impaired liver function (transaminase >2x than normal)

•Impaired kidney function (creatinin > 1,2 mg/dl)

•Known intolerance against GLP-1 receptor agonists

•History of pancreatitis or pancreas tumor

•Malignancies, autoimmune diseases

•Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)

•Psychiatric disorder

•Oral glucose lowering medication except for metformin

Endpoints (3)

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

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to End of Study

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), weight in kg	95% CI
Lixisenatide With Basal Insulin (LixiBIT)	-1.4	—

p0.28paired t test

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to End

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), HbA1c in percent	95% CI
Lixisenatide With Basal Insulin (LixiBIT)	-0.54	—

p<0.02paired t test

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)

Time frame:12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), glucose in mg/dl	95% CI
Lixisenatide With Basal Insulin (LixiBIT)	-9	-24.1 – 6.1

p0.24paired t test

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

Switch to Combined GLP1 Receptor Agonist Lixisenatide with Basal Insulin Glargine in Poorly Controlled T2DM Patients with Premixed Insulin Therapy: A Clinical Observation and Pilot Study in Nine Patients.
Diabetes therapy : research, treatment and education of diabetes and related disorders2017 Jun (month)PMID28357772doi:10.1007/s13300-017-0249-4via 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.