DelfaGLP-1 Atlas

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Lixi

UnknownPhase 1, PHASE2

Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI 19-30•HbA1c 6-8.5%•Healthy volunteers

Primary endpoint

•Blood Pressure

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 IDNCT02308254
Org study ID130419

Timeline

Milestones

Study first posted2014-12-04estimated
Last update posted2015-10-29estimated
Study start2013-11 (month precision)
Primary completion2016-04estimated (month precision)
Study completion2016-04estimated (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Healthy subjects:
–Male or female (females using appropriate contraceptive method or willing to undergo pregnancy test)
–Body Mass Index (BMI) 19 - 30 kg/m2
•Type 2 Diabetic Patients:
–As per "healthy subjects"
–Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or on metformin
–Glycated haemoglobin >6.0% and <8.5%

Exclusion criteria

•Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestations of the disease, or living with the condition, impact negatively and significantly on the individuals' ability to lead a normal day to day life), chronic alcohol abuse or epilepsy (excluded by history) or if iron status, or liver function tests are outside the following ranges:

1. Alanine aminotransferase (ALT) 0 - 55 U/L

2. Alkaline phosphatase 30 - 110 U/L

3. Aspartate transaminase 0 - 45 U/L

4. Amylase and/or lipase >3 x ULN

5. Bilirubin 6 - 24 mmol/L

6. Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)

7. Haemoglobin 115 - 155 g/L (females); 135 - 172 g/L (males)

•Subjects with a creatinine clearance cut-off of <50 ml/min
•Subjects requiring medication likely to influence blood pressure or gastrointestinal function
•Subjects with a past history of gastrointestinal disease, including known gastroparesis, significant upper gastrointestinal symptoms and previous gastric surgery
•Subjects with a past history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
•Subjects with a current or prior history of c-cell carcinoma
•Smoking > 10 cigarettes/day
•Alchohol consumption > 20 g/day
•Subjects who have donated blood in the previous 12 weeks
•Women of childbearing potential with no effective contraceptive method (defined as premenopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative urine B-hCG pregnancy test at screening visit. They must also use an effective contraceptive method throughout the study, and agree to repeat urine pregnancy test at designated visits.
•Lactation

Endpoints (10)

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
3
Other (unclassified)
3
Glycemic / diabetes
1
Patient-reported / QoL
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

Blood glucose concentration

Time frame:3 hours per study

descriptive, improvement

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

Blood Pressure

Time frame:4.5 hours per study

descriptive, improvement

Secondary/protocol endpoint

Heart rate

Time frame:4.5 hours per study

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Cardiac output

Time frame:3.5 hours per study

descriptive

Patient-reported / QoL

1 endpoint
Other/protocol endpoint

Appetite (visual analogue questionnaire)

Time frame:4.5 hours per study

descriptive

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint/low confidence

Gastrointestinal hormone release (concentrations of GLP-1, GIP, C-peptide and 3-OMG)

Time frame:4.5 hours per study

concentration, descriptive

componentsglp1 concentration, gip concentration, C-peptide AUC, 3 omg concentration

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Gastric emptying rate

Time frame:3 hours per study

descriptive

Other (unclassified)

3 endpoints
Other/protocol endpoint/low confidence

Intragastric distribution

Time frame:3 hours per study

percent change from baseline, descriptive

Other/protocol endpoint/low confidence

Superior mesenteric artery blood flow

Time frame:3.5 hours per study

descriptive

Other/protocol endpoint/low confidence

Stroke volume

Time frame:3.5 hours per study

descriptive

Publications (32)

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.