LEAD-5

CompletedPhase 3

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

116

Recruiting sites

—

Enrollment

584

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.5-10%

Primary endpoint

•HbA1c, 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 IDNCT00331851

Org study IDNN2211-1697

Timeline

Milestones

Study first posted2006-05-31estimated

Last update posted2017-01-26estimated

Study start2006-05 (month precision)

Primary completion2007-04actual (month precision)

Study completion2007-04actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Treatment with oral anti-diabetic drugs for at least 3 months

•HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy.

•Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion criteria

•Treatment with insulin within the last 3 months

•Treatment with any drug that could interfere with the glucose level

•Any serious medical condition

•Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Endpoints (5)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

body weight

descriptive, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

HbA1c

Time frame:after 26 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Beta-cell function

descriptive, improvement

Secondary/protocol endpoint/low confidence

Glycaemic control

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety and tolerability

Treatment-emergent AEs (any)

descriptive

Publications (14)

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

Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials.
Diabetes care2015 Jun (month)PMID25504028doi:10.2337/dc13-1210via CT.gov reference
Is insulin the most effective injectable antihyperglycaemic therapy?
Diabetes, obesity & metabolism2015 Feb (month)PMID25323312doi:10.1111/dom.12402via CT.gov reference
Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials.
Journal of diabetes and its complications2014 May-Jun (year)PMID24561125doi:10.1016/j.jdiacomp.2014.01.009via clinicaltrials gov reference derived + pubmed nct search
Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2013 Jan-Feb (year)PMID23186975doi:10.4158/EP12232.ORvia CT.gov reference
Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.
Diabetes, obesity & metabolism2013 Jan (month)PMID22862847doi:10.1111/j.1463-1326.2012.01673.xvia CT.gov reference
A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.
Diabetes research and clinical practice2012 Nov (month)PMID23010561doi:10.1016/j.diabres.2012.09.008via CT.gov reference
Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme.
Diabetes, obesity & metabolism2012 Jan (month)PMID21883806doi:10.1111/j.1463-1326.2011.01493.xvia CT.gov reference
Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies.
The American journal of geriatric pharmacotherapy2011 Dec (month)PMID22055210doi:10.1016/j.amjopharm.2011.09.007via CT.gov reference
Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials.
The Journal of clinical endocrinology and metabolism2011 Jun (month)PMID21450987doi:10.1210/jc.2010-2822via CT.gov reference + pubmed nct search
Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2011 Nov-Dec (year)PMID22193143doi:10.4158/ep.17.6.906via CT.gov reference
The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies.
Diabetes, obesity & metabolism2009 Dec (month)PMID19878259doi:10.1111/j.1463-1326.2009.01075.xvia CT.gov reference
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.
Diabetologia2009 Oct (month)PMID19688338doi:10.1007/s00125-009-1472-yvia CT.gov reference + pubmed nct search
Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies.
Postgraduate medicine2009 May (month)PMID19491536doi:10.3810/pgm.2009.05.1998via CT.gov reference
Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone.
Cardiovascular diabetology2009 Feb 26PMID19245711doi:10.1186/1475-2840-8-12via CT.gov reference + pubmed nct search

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.