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Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
Addition of a Glucagon-like Peptide-1 to a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and Cardiovascular Disease.
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
69
actual
Study population
Obesity / overweight, Prediabetes / glucose intolerance
Key I/E criterion
•BMI 27-37
Primary endpoint
•Body weight, absolute change (kg)
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
IFG, or IGT BMI 27.0-37.0 kg/m2
Exclusion criteria
DM, CAD, severe anemia, kidney or liver disease, hx of pancreatitis, gallstones, ETOH abuse, personnel or family history of medullary thyroid carcinoma or MEN-2
Endpoints (6)
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
Weight & body composition
2 endpointsChange in Weight Reported at 14 Weeks
Time frame:Baseline and 14 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Placebo | -3.3 | -4.1 – -2.5 |
| Liraglutide | -6.8 | -7.8 – -5.9 |
Change in Weight Reported at 14 Weeks
Time frame:Baseline and 14 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
4 endpointsGlucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H
Time frame:Baseline, 14 weeks
C-peptide AUC
change from baseline, improvement
Posted result
| Group | Value (mean), pmol/l x4 h | 95% CI |
|---|---|---|
| Placebo | -7.3 | -17 – 2 |
| Liraglutide | 34 | 21 – 48 |
Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction
Time frame:Baseline, 14 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Placebo | 2.8 | — |
| Liraglutide | -57.5 | — |
Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H
Time frame:Baseline, 14 weeks
change from baseline, improvement
Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction
Time frame:Baseline, 14 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Publications (2)
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
- Diabetologia2014 Mar (month)PMID24326527doi:10.1007/s00125-013-3134-3via clinicaltrials gov reference derived + pubmed nct search
- Diabetes care2013 Oct (month)PMID23835684doi:10.2337/dc13-0354via clinicaltrials gov reference derived + pubmed nct search
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.