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PRODIGIES

UnknownPhase NA

Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines

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 ≤35HbA1c ≥7%

Primary endpoints

Custom renal composite (eGFR, change, uACR, change)The microvascular complications of type 2 diabetes, specifically RetinopathyThe 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

NCT IDNCT01974544
Org study ID11-141

Timeline

Milestones

Study first posted2013-11-01estimated
Last update posted2013-11-01estimated
Study start2013-05 (month precision)
Primary completion2015-12estimated (month precision)
Study completion2016-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric SurgeryChronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Other clinical outcomes
2
Cardiovascular outcomes
1
Glycemic / diabetes
1
Renal / kidney
1
Patient-reported / QoL
1
Safety / tolerability / PK
1
Other (unclassified)
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

Assessment 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 endpoint
Secondary/protocol endpoint

How 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 endpoint
Primary/protocol endpoint

Change 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 endpoint
Secondary/protocol endpoint

Assessment 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 endpoint
Secondary/protocol endpoint

Assessment 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 endpoints
Primary/protocol endpoint

Change 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

Primary/protocol endpoint

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 endpoint
Secondary/protocol endpoint/low confidence

Assessment 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 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.