DelfaGLP-1 Atlas

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CompletedPhase 4

Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment

Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

40

estimated

Study population

Bariatric Surgery, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 27-32•HbA1c ≥8%

Primary endpoints

•HbA1c <6.0% achievement•Systolic BP, change•LDL-C, change

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 IDNCT02041234
Org study IDBariatric Surgery RCT

Timeline

Milestones

Study first posted2014-01-22estimated
Last update posted2022-06-23actual
Study start2014-02 (month precision)
Primary completion2020-12actual (month precision)
Study completion2022-06actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Established diagnosis of DM2 = or < 10 years

2. Age 21-65

3. BMI 27-32.

4. HBA1c ≥ 8%, on maximum treatment from primary care physician

5. At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class I nephropathy, retinopathy.

Exclusion criteria

1. Subjects who had previous Bariatric surgery or extensive upper abdominal surgery

2. Pregnant subjects.

3. Nephropathy requiring dialysis

4. Subjects who are not fit for general anaesthesia.

5. Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological.

6. Subjects who are unwilling or possibly unable to participate in the follow up process.

7. Subjects who are reluctant to be randomised into the two study groups.

8. Subjects who suffers from unstable psychiatric illness

9. Subjects who are active substance abusers

10. Glutamic acid decarboxylase antibody positive.

11. fasting C-peptide < 300 pmol/L

Endpoints (16)

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
5
Cardiometabolic biomarkers
5
Other (unclassified)
4
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight loss

Time frame:12 months post randomisation

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Number of subjects achieving HBA1c of 6% without diabetic medication

Time frame:at 12 month after randomisation

HbA1c <6.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

fasting plasma glucose

Time frame:12 months after Randomisation

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting Insulin

Time frame:12 months after radomisation

change from baseline, improvement

Secondary/protocol endpoint

serum c-peptide level

Time frame:12 months post randomisation

change from baseline, improvement

Secondary/protocol endpoint

HOMA-IR

Time frame:12 months post randomisation

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints
Primary/protocol endpoint

Number of subjects achieving systolic BP <130mm hg without antihypertension medication

Time frame:12 months post randomisation

Systolic BP, change

threshold achievement, improvement

LOINC 8480-6

Primary/protocol endpoint

number of subjects achieving LDL level of <100mg/dl without lipid lowering medication

Time frame:12 months post randomisation

LDL-C, change

threshold achievement, improvement

LOINC 13457-7

Secondary/protocol endpoint

serum lipid levels

Time frame:12 months post randomisation

descriptive, improvement

Secondary/protocol endpoint

C-reactive protein level

Time frame:12 months post randolmisation

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Blood Pressure measurement

Time frame:12 months post randomisation

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

number of adverse events

Time frame:12 months post randomisaiton

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

change in medications usage

Time frame:12 months post randomisation

descriptive

Secondary/protocol endpoint/low confidence

changes in gut hormones levels

Time frame:12 months post randomisation

change from baseline, improvement

Secondary/protocol endpoint/low confidence

changes in metabolic hormones level

Time frame:12 months post randomisation

change from baseline, improvement

Secondary/protocol endpoint/low confidence

health resource utilisation

Time frame:12 months post randomisation

descriptive

Publications (9)

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.