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PILGRIM

CompletedPhase NA

Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus

PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

Enrollment

150

actual

Study population

Perioperative / gastric aspiration risk, Type 2 diabetes

Key I/E criterion

Primary endpoint

Median glucose

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 IDNCT02036372
Org study IDNL 41467.018.12

Timeline

Milestones

Study first posted2014-01-15estimated
Last update posted2023-07-20actual
Study start2014-01actual (month precision)
Primary completion2017-01actual (month precision)
Study completion2017-01actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Perioperative / gastric aspiration riskType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Signed informed consent
known diabetes mellitus type II for > 3 months
aged 18-75 years
scheduled for elective non-cardiac surgery

Exclusion criteria

- Daily insulin dosage of > 1 IU/kg body weight

Oral corticosteroid use
Planned for day-care (ambulant) surgery
Planned ICU stay post-operatively
Planned bowel surgery
History of chronic pancreatitis or idiopathic acute pancreatitis
Impaired renal function defined as serum-creatinine ≥ 133 μmol/L for males and ≥ 115 μmol/L for females
Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Known or suspected allergy to trial product(s) or related products
Any condition that the local investigator feels would interfere with trial participation or the evaluation of results

Endpoints (7)

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
4
Safety / tolerability / PK
3

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Median glucose

Time frame:1 hour after surgery

change from baseline, improvement

Secondary/protocol endpoint

Total Insulin administration

Time frame:1 day postoperative

event count, improvement

Secondary/protocol endpoint/low confidence

Median glucose

Time frame:4 hours and 1 day postoperative

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Glucose

Time frame:From start treatment until morning of day 1 postoperative

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Postoperative complications

Time frame:1 month after surgery

threshold achievement, event

Secondary/protocol endpoint

Hypoglycemia

Time frame:From start treatment until the morning of day 1 postoperative

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypo- and hyperkalemia

Time frame:from start treatment until morning of day 1 postoperative

threshold achievement, event

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.