← Trials/Trial dossier/NCT01974544
PRODIGIES
UnknownPhase NAPrevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
150
estimated
Study population
Bariatric Surgery, Chronic kidney disease, Type 2 diabetes
Key I/E criteria
•BMI ≤35•HbA1c ≥7%
Primary endpoints
•Custom renal composite (eGFR, change, uACR, change)•The microvascular complications of type 2 diabetes, specifically Retinopathy•The microvascular complications of type 2 diabetes, specifically peripheral
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Type 2 diabetes with HbA1c > 7%
2. Duration of diabetes of more than 2 years
3. The glomerular filtration rate (GFR) > 30 ml/min per 1.73 m2
4. BMI < 35 kg/m2
5. Age 18-65
6. Established microalbuminuria or at high risk of microalbuminuria
Exclusion criteria
1. Type 1 diabetes or positive Glutamic acid decarboxylase antibodies (Anti-GAD)
2. BMI >35 kg/m2
3. End stage retinopathy, nephropathy or neuropathy (defined as high risk/advanced proliferative retinopathy on the Early Treatment Diabetic Retinopathy Study Severity Scale or blindness, Stage 5 chronic kidney disease, patients requiring dialysis or transplantation, Stage 3 peripheral neuropathy)
4. Unacceptably high risk for general anaesthesia.
Endpoints (8)
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
Cardiovascular outcomes
1 endpointAssessment of macrovascular events
Time frame:baseline at 1 month before the intervention and 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after the intervention
Expanded / custom MACE composite
event count, event
componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Peripheral revascularization, Major amputation
Glycemic / diabetes
1 endpointHow many patients not requiring antidiabetic agents
Time frame:baseline 1 month after intervention, and at 6, 12, 18, 24, 30, and 36 month after intervention
threshold achievement, improvement
Renal / kidney
1 endpointChange in the microvascular complications of type 2 diabetes, specifically diabetic kidney disease
Time frame:baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention
Custom renal composite
composite event, improvement
componentseGFR, change, uACR, change
Patient-reported / QoL
1 endpointAssessment of the quality of life.
Time frame:baseline at 1 month before the intervention and 3, 6, 12, and 24 month after the intervention
descriptive, improvement
Safety / tolerability / PK
1 endpointAssessment of treatment complications
Time frame:1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention
descriptive, event
Other clinical outcomes
2 endpointsChange in the microvascular complications of type 2 diabetes, specifically Retinopathy.
Time frame:baseline at 1 month before the intervention, 12 y 24 month after intervention
change from baseline, improvement
Change in the microvascular complications of type 2 diabetes, specifically peripheral and sympathic neuropathy.
Time frame:baseline at 1 month before the intervention, 12, 24 y 36 month
change from baseline, improvement
Other (unclassified)
1 endpointAssessment of the optimization of the metabolic control, defined by the International Diabetes Federation
Time frame:baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after the intervention
descriptive, improvement
Provenance
Sources
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.