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CompletedPhase 1

Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

43

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 27-40HbA1c 6.5-10%

Primary endpoint

Energy intake at a standardised buffet meal with a preload paradigm quantified

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 IDNCT01511692
Org study IDNN2211-1589
Secondary ID2006-000377-30

Timeline

Milestones

Study first posted2012-01-19estimated
Last update posted2017-01-25estimated
Study start2005-11 (month precision)
Primary completion2007-09actual (month precision)
Study completion2007-09actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Type 2 diabetes mellitus
Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
Body mass index (BMI) between 27-40 kg/m^2 (both inclusive)
Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
Euthyroid subjects
Subjects should be unrestrained eaters

Exclusion criteria

Recurrent severe hypoglycaemia
Impaired liver function
Impaired renal function
Cardiac problems
Uncontrolled treated/untreated hypertension
Known or suspected allergy to trial products or related products
Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
Active hepatitis B and/or active hepatitis C
Positive HIV (human immunodeficiency virus) antibodies
Known or suspected abuse of alcohol or narcotics
Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator

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
5
Weight & body composition
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint/low confidence

Weight

descriptive, improvement

Secondary/protocol endpoint

Waist circumference

Waist circumference, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

Other clinical outcomes

5 endpoints
Primary/protocol endpoint/low confidence

The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10

descriptive

Secondary/protocol endpoint/low confidence

The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10

descriptive

Secondary/protocol endpoint/low confidence

Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10

descriptive

Secondary/protocol endpoint

Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10

descriptive

Secondary/protocol endpoint

Total duration of eating at the buffet meal (satiation)

descriptive

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.