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CompletedPhase 4

Lixisenatide-The Effects on Glucose and Lipid Metabolism in Type 2 Diabetes

The Effect of Lixisenatide on Postprandial Lipid and Glucose Metabolism in Patients with Type 2 Diabetes

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

8

Study population

Type 2 diabetes

Eligibility highlights

•BMI 27-40•HbA1c ≥0.5%•Male

Primary endpoint

•Postprandial glucose

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02049034
Org study IDLIXISL06684
Secondary ID2013-002826-22

Timeline

Milestones

Study first posted2014-01-29estimated
Last update posted2024-12-16actual
Study start2014-01 (month precision)
Primary completion2016-01actual (month precision)
Study completion2016-01actual (month precision)

Assets

Investigational agents

Lixisenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age40 Years
Maximum age65 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•Subjects with type 2 diabetes inadequately controlled by metformin.
•Stable diabetes management over last 3 months: metformin dose unchanged. HbA1c not known to have changed by >0.5% over 3 months.
•Caucasian
•Male
•40-65 years (inclusive)
•HbA1c 7.5-9.5% (inclusive)
•BMI 27-40 kg/m2 (inclusive)
•Able and willing to self-administer placebo/lixisenatide injection
•Able and willing to perform self-blood glucose monitoring.
•Able and willing to wear a Continuous Glucose Monitoring System (CGMS) for 3 days

Exclusion criteria

•Subjects treated with insulin, any oral hypoglycaemic agents (OHA) (other than metformin), any insulin secretagogue or Thiazolidinediones (TZDs)
•A history of heavy alcohol use (>12 to 15 g of alcohol per day)
•Arteriopathy
-History of significant coronary artery disease (myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥ 50% in a major epicardial artery or branch vessel)
-Ischemic cerebrovascular disease, including:
-History of ischemic stroke.
-History of carotid arterial disease as documented by ≥ 50 % stenosis documented by carotid ultrasound, magnetic resonance imaging or angiography, with or without neurological sequelae.
-Atherosclerotic peripheral arterial disease, as documented by history of amputation due to vascular disease; history of surgical or percutaneous revascularization procedure; current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index less than 0.9
•Hepatic disease: alanine transaminase (ALT) >3 times upper limit of normal (ULN)
•Renal disease: estimated glomerular filtration rate (Cockroft-Gault equation) less than 40ml/minute.
•Subjects receiving fibrates or weight reducing drugs
•Mental incapacity
•Unwillingness or a language barrier precluding adequate understanding or co-operation
•Fasting plasma triglycerides >4.0 mmol/l
•Systolic blood pressure >160 mmHg on 2 occasions, measured at least 10-minutes apart
•Screening amylase and/or lipase > 3 times ULN or P-calcitonin ≥20 pg/ml (5.9 pmol/L).
•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
•Any stomach/gastric surgery other than minor endoscopic procedures such as peptic ulcer injection
•Allergic reaction to any GLP-1 receptor agonist or to metacresol.
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
•Current smokers
•Subject enrolled in another experimental protocol which involves the use of an investigational drug or device

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
1
Cardiometabolic biomarkers
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Postprandial glucose kinetics

Time frame:Two years

Postprandial glucose

descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Postprandial and intestinal triglyceride-rich lipoproteins (TRL) kinetics

Time frame:Two years

descriptive

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Post heparin lipoprotein lipase activity

Time frame:Two years

change from baseline, 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 6, 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 6, 2026 snapshot.