← Trials/Trial dossier/NCT01288326

ROOTS

Completed

Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

254

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

HbA1c, % changeHbA1c, 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 IDNCT01288326
Org study IDNN2211-3876
Secondary IDU1111-1116-2199WHO

Timeline

Milestones

Study first posted2011-02-02estimated
Last update posted2017-01-26estimated
Study start2011-02 (month precision)
Primary completion2013-03actual (month precision)
Study completion2013-03actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

Study population text

Subjects with type 2 diabetes mellitus for whom physicians determine that liraglutide is an appropriate new treatment.

Inclusion criteria

Type 2 diabetes
Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)

Exclusion criteria

Previously treated with liraglutide
Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
Pregnant, breast feeding or have the intention of becoming pregnant

Endpoints (7)

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
4
Safety / tolerability / PK
3

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%

Time frame:month 12

HbA1c, % change

threshold achievement, improvement

LOINC 4548-4

Primary/protocol endpoint

Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%

Time frame:month 12

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c

Time frame:month 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting blood glucose (FBG)

Time frame:month 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Incidence of serious adverse events (SAEs)

Time frame:months 0-12

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Incidence of adverse drug reactions (ADRs)

Time frame:months 0-12

event count, event

Secondary/protocol endpoint

Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)

Time frame:months 0-12

Documented hypoglycemia

event count, event

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.