DelfaGLP-1 Atlas

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ELIXIRS

CompletedPhase 4

Effect of LIXIsenatide on the Renal System

A Phase 4, Mono-center, Randomized, Open Label, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist Lixisenatide Versus Insulin Glulisine on Renal Physiology and Biomarkers in Insulin Glargine-treated Patients With Type 2 Diabetes Mellitus

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

40

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 6.5-10%

Primary endpoint

•Changes from baseline following 8-week treatment

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 IDNCT02276196
Org study IDDC2014ELIX001

Timeline

Milestones

Study first posted2014-10-28estimated
Last update posted2016-04-29estimated
Study start2014-09 (month precision)
Primary completion2016-04actual (month precision)
Study completion2016-04actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes (HbA1c: 6.5-10.0% or 48-86 mmol/mol)
•Stable treatment with basal insulin glargine (dose ±20%) and metformin or basal insulin glargine (dose ±20%) alone for at least 3 months
•Fasting plasma glucose <10 mmol/L or the use of >50 units of basal insulin glargine
•Females must be post-menopausal
•Caucasian
•Age: 35 - 75 years
•Body Mass Index: >25 kg/m2
•Hypertension should be under control, i.e. <140/90 mmHg, and treated with an angiotensin-converting enzyme inhibitor or angiotensin-II-receptor blocker for at least 3 months.
•Albuminuria should be treated with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin-II-receptor blocker (ARB) for at least 3 months.

Exclusion criteria

•Current/chronic use of the following medication: thiazolidinediones, sulfonylurea derivatives, GLP-1 receptor agonists, dipeptidyl peptidase (DPP)-4 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants and monoamine oxidase inhibitors. Subjects on diuretics, will only be excluded when these drugs cannot be stopped for the duration of the study.
•Chronic use of non-steroidal anti-inflammatory drugs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
•Hypoglycemia unawareness based on investigator judgment
•History of severe hypoglycemia that required emergency hospital treatment within 3 months prior to screening
•Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
•Pregnancy
•Current urinary tract infection and active nephritis
•Recent (<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke or transient ischemic neurologic disorder
•Complaints compatible with or established gastroparesis, neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
•Active liver disease or a 3-fold elevation of liver enzymes (aspartate aminotransferase/alanine aminotransferase) at screening
•History of or actual pancreatic disease
•History of or actual malignancy (except basal cell carcinoma)
•History of or actual severe mental disease
•Substance abuse (alcohol: defined as >4 units/day)
•Allergy to any of the agents used in the study
•Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study
•Inability to understand the study protocol or give informed consent

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

Cardiometabolic biomarkers
4
Renal / kidney
3
Other (unclassified)
3
Weight & body composition
2
Glycemic / diabetes
1

Weight & body composition

2 endpoints
Other/protocol endpoint

Body anthropometrics: body weight, height, body mass index, waist circumference

Time frame:8 weeks

descriptive

Other/protocol endpoint

Body fat content

Time frame:8 weeks

Total fat mass

descriptive, improvement

Glycemic / diabetes

1 endpoint
Other/protocol endpoint/low confidence

Glycemic variables

Time frame:8 weeks

descriptive

Renal / kidney

3 endpoints
Primary/protocol endpoint

Changes from baseline following 8-week treatment with a glucagon-like peptide(GLP)-1 receptor agonist versus insulin glulisine on renal hemodynamics, measured as glomerular filtration rate (GFR) / effective renal plasma flow (ERPF)

Time frame:8 weeks

ratio, improvement

Secondary/protocol endpoint/low confidence

Renal damage, measured by urine biomarkers

Time frame:8 weeks

descriptive

Secondary/protocol endpoint/low confidence

Renal tubular function

Time frame:8 weeks

percent change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Blood Pressure

Time frame:8 weeks

descriptive, improvement

Other/protocol endpoint/low confidence

Lipid spectrum

Time frame:8 weeks

change from baseline, improvement

Other/protocol endpoint

Heart rate

Time frame:8 weeks

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Arterial stiffness

Time frame:8 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints
Other/protocol endpoint/low confidence

Inflammatory markers

Time frame:8 weeks

descriptive

Other/protocol endpoint/low confidence

Systemic hemodynamic variables

Time frame:8 weeks

descriptive

Other/protocol endpoint/low confidence

Microvascular function

Time frame:8 weeks

descriptive

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.