LEAD-2

CompletedPhase 3Results posted

To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

190

Recruiting sites

—

Enrollment

1,091

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-11%

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 IDNCT00318461

Org study IDNN2211-1572

Timeline

Milestones

Study first posted2006-04-26estimated

Results first posted2010-03-12estimated

Last update posted2017-03-07actual

Study start2006-05 (month precision)

Primary completion2007-05actual (month precision)

Study completion2008-11actual (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

•Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months

•HbA1c: 7.0-11.0 % (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 40 kg/m2

Exclusion criteria

•Subjects treated with insulin within the last three months

•Subjects with any serious medical condition

•Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods

•Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

Endpoints (28)

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

4 endpoints

Secondary/registry result

Change in Body Weight at Week 26

Time frame:week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 0.6 + Met	-1.78	—
Lira 1.2 + Met	-2.58	—
Lira 1.8 + Met	-2.79	—
Met Mono	-1.51	—
Met + Glim	0.95	—

Estimated treatment difference, LS Mean-1.2995% CI-2.16 – -0.41p0.0016ANCOVA

Estimated treatment difference, LS Mean-3.7595% CI-4.48 – -3.01p<0.0001ANCOVA

Estimated treatment difference, LS Mean-1.0795% CI-1.94 – -0.19p0.0117ANCOVA

Estimated treatment difference, LS Mean-3.5395% CI-4.27 – -2.79p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.2895% CI-1.15 – 0.60p0.8198ANCOVA

Estimated treatment difference, LS Mean-2.7395% CI-3.47 – -2.00p<0.0001ANCOVA

Secondary/registry result

Change in Body Weight at Week 104

Time frame:week 0, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 0.6 + Met	-2.07	—
Lira 1.2 + Met	-3.03	—
Lira 1.8 + Met	-2.91	—
Met Mono	-1.80	—
Met + Glim	0.70	—

Estimated treatment difference, LS Mean-1.1195% CI-2.18 – -0.05p0.0378ANCOVA

Estimated treatment difference, LS Mean-3.6195% CI-4.51 – -2.72p<0.0001ANCOVA

Estimated treatment difference, LS Mean-1.2395% CI-2.30 – -0.16p0.0185ANCOVA

Estimated treatment difference, LS Mean-3.7395% CI-4.64 – -2.83p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.2795% CI-1.33 – 0.80p0.9069ANCOVA

Estimated treatment difference, LS Mean-2.7795% CI-3.67 – -1.87p<0.0001ANCOVA

Secondary/protocol endpoint

Change in Body Weight at Week 26

Time frame:week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight at Week 104

Time frame:week 0, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

20 endpoints

Primary/registry result

Change in Glycosylated A1c (HbA1c) at Week 26

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage point of total HbA1c	95% CI
Lira 0.6 + Met	-0.69	—
Lira 1.2 + Met	-0.97	—
Lira 1.8 + Met	-1.00	—
Met Mono	0.09	—
Met + Glim	-0.98	—

Estimated treatment difference, LS Mean-1.0995% CI-1.30 – -0.88p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.0295% CI-0.19 – 0.15p<0.0001ANCOVA

Estimated treatment difference, LS Mean-1.0695% CI-1.27 – -0.85p<0.0001ANCOVA

Estimated treatment difference, LS Mean0.0195% CI-0.16 – 0.18p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.7895% CI-0.99 – -0.57p<0.0001ANCOVA

Estimated treatment difference, LS Mean0.2995% CI0.12 – 0.46p0.1026ANCOVA

Estimated treatment difference, LS Mean-1.0795% CI-1.28 – -0.86p<0.0001ANCOVA

Primary/registry result

Change in Glycosylated A1c (HbA1c) at Week 104

Time frame:week 0, week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total haemoglobin	95% CI
Lira 0.6 + Met	-0.36	—
Lira 1.2 + Met	-0.56	—
Lira 1.8 + Met	-0.58	—
Met Mono	0.25	—
Met + Glim	-0.50	—

Estimated treatment difference, LS Mean-0.8395% CI-1.07 – -0.59p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.0895% CI-0.28 – 0.12p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.8195% CI-1.05 – -0.57p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.0795% CI-0.27 – 0.13p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.6195% CI-0.85 – -0.37p<0.0001ANCOVA

Estimated treatment difference, LS Mean0.1495% CI-0.06 – 0.34p0.0052ANCOVA

Estimated treatment difference, LS Mean-0.7595% CI-0.99 – -0.51p<0.0001ANCOVA

Primary/protocol endpoint

Change in Glycosylated A1c (HbA1c) at Week 26

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change in Glycosylated A1c (HbA1c) at Week 104

Time frame:week 0, week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG) at Week 26

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 0.6 + Met	-1.13	—
Lira 1.2 + Met	-1.63	—
Lira 1.8 + Met	-1.68	—
Met Mono	0.40	—
Met + Glim	-1.31	—

Estimated treatment difference, LS Mean-2.0995% CI-2.68 – -1.50p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.3895% CI-0.87 – 0.11p0.1845ANCOVA

Estimated treatment difference, LS Mean-2.0495% CI-2.63 – -1.44p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.3395% CI-0.82 – 0.17p0.3047ANCOVA

Estimated treatment difference, LS Mean-1.5395% CI-2.12 – -0.94p<0.0001ANCOVA

Estimated treatment difference, LS Mean0.1895% CI-0.32 – 0.67p0.8079ANCOVA

Secondary/registry result

Change in Fasting Plasma Glucose (FPG) at Week 104

Time frame:week 0, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 0.6 + Met	-0.80	—
Lira 1.2 + Met	-1.20	—
Lira 1.8 + Met	-1.18	—
Met Mono	0.75	—
Met + Glim	-0.64	—

Estimated treatment difference, LS Mean-1.9395% CI-2.58 – -1.28p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.5395% CI-1.08 – 0.01p0.0542ANCOVA

Estimated treatment difference, LS Mean-1.9595% CI-2.60 – -1.30p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.5595% CI-1.10 – -0.01p0.0451ANCOVA

Estimated treatment difference, LS Mean-1.5595% CI-2.20 – -0.90p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.1595% CI-0.70 – 0.39p0.9006ANCOVA

Secondary/registry result

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/l	95% CI
Lira 0.6 + Met	-0.23	—
Lira 1.2 + Met	-0.40	—
Lira 1.8 + Met	-0.56	—
Met Mono	-0.44	—
Met + Glim	-0.44	—

Estimated treatment difference, LS Mean-0.1395% CI-0.62 – 0.36p0.8871ANCOVA

Estimated treatment difference, LS Mean-0.1295% CI-0.51 – 0.27p0.8695ANCOVA

Estimated treatment difference, LS Mean0.0395% CI-0.46 – 0.52p0.9994ANCOVA

Estimated treatment difference, LS Mean0.0495% CI-0.35 – 0.43p0.9984ANCOVA

Estimated treatment difference, LS Mean0.2195% CI-0.28 – 0.70p0.6201ANCOVA

Estimated treatment difference, LS Mean0.2195% CI-0.18 – 0.60p0.4831ANCOVA

Secondary/registry result

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Time frame:week 0, week 104

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 0.6 + Met	-0.27	—
Lira 1.2 + Met	-0.56	—
Lira 1.8 + Met	-0.44	—
Met Mono	-0.20	—
Met + Glim	-0.29	—

Estimated treatment difference, LS Mean-0.2495% CI-0.74 – 0.26p0.5282ANCOVA

Estimated treatment difference, LS Mean-0.1595% CI-0.55 – 0.25p0.7644ANCOVA

Estimated treatment difference, LS Mean-0.3695% CI-0.86 – 0.14p0.2063ANCOVA

Estimated treatment difference, LS Mean-0.2895% CI-0.68 – 0.12p0.2678ANCOVA

Estimated treatment difference, LS Mean-0.0795% CI-0.57 – 0.43p0.9887ANCOVA

Estimated treatment difference, LS Mean0.0295% CI-0.38 – 0.42p0.9998ANCOVA

Secondary/registry result

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 0.6 + Met	-1.68	—
Lira 1.2 + Met	-2.33	—
Lira 1.8 + Met	-2.57	—
Met Mono	-0.62	—
Met + Glim	-2.46	—

Estimated treatment difference, LS Mean-1.9595% CI-2.60 – -1.30p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.1195% CI-0.62 – 0.41p0.9670ANCOVA

Estimated treatment difference, LS Mean-1.7295% CI-2.36 – -1.07p<0.0001ANCOVA

Estimated treatment difference, LS Mean0.1395% CI-0.39 – 0.64p0.9368ANCOVA

Estimated treatment difference, LS Mean-1.0695% CI-1.71 – -0.42p0.0003ANCOVA

Estimated treatment difference, LS Mean0.7895% CI0.27 – 1.29p0.0008ANCOVA

Secondary/registry result

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Time frame:week 0, week 104

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 0.6 + Met	-1.59	—
Lira 1.2 + Met	-2.22	—
Lira 1.8 + Met	-2.10	—
Met Mono	-0.43	—
Met + Glim	-1.80	—

Estimated treatment difference, LS Mean-1.6695% CI-2.37 – -0.96p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.3095% CI-0.86 – 0.26p0.5048ANCOVA

Estimated treatment difference, LS Mean-1.7995% CI-2.49 – -1.08p<0.0001ANCOVA

Estimated treatment difference, LS Mean-0.4295% CI-0.98 – 0.14p0.2005ANCOVA

Estimated treatment difference, LS Mean-1.1695% CI-1.86 – -0.46p0.0003ANCOVA

Estimated treatment difference, LS Mean0.2195% CI-0.35 – 0.76p0.7871ANCOVA

Secondary/registry result

Change in Beta-cell Function at Week 26

Time frame:week 0, week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage point (%point)	95% CI
Lira 0.6 + Met	20.45	—
Lira 1.2 + Met	20.33	—
Lira 1.8 + Met	26.12	—
Met Mono	-1.63	—
Met + Glim	24.68	—

Estimated treatment difference, LS Mean27.7595% CI7.83 – 47.67p0.0031ANCOVA

Estimated treatment difference, LS Mean1.4495% CI-15.03 – 17.90p0.9987ANCOVA

Estimated treatment difference, LS Mean21.9695% CI2.04 – 41.87p0.0263ANCOVA

Estimated treatment difference, LS Mean-4.3695% CI-20.94 – 12.22p0.9227ANCOVA

Estimated treatment difference, LS Mean22.0895% CI2.15 – 42.01p0.0253ANCOVA

Estimated treatment difference, LS Mean-4.2395% CI-20.78 – 12.31p0.9293ANCOVA

Secondary/registry result/low confidence

Change in Beta-cell Function at Week 104

Time frame:week 0, week 104

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage point (%point)	95% CI
Lira 0.6 + Met	64.48	—
Lira 1.2 + Met	27.30	—
Lira 1.8 + Met	17.81	—
Met Mono	-7.89	—
Met + Glim	11.25	—

Estimated treatment difference, LS Mean25.7195% CI-69.84 – 121.26p0.8821ANCOVA

Estimated treatment difference, LS Mean6.5695% CI-72.66 – 85.79p0.9989ANCOVA

Estimated treatment difference, LS Mean35.2095% CI-60.33 – 130.72p0.7292ANCOVA

Estimated treatment difference, LS Mean16.0595% CI-63.69 – 95.79p0.9689ANCOVA

Estimated treatment difference, LS Mean72.3895% CI-23.15 – 167.90p0.1818ANCOVA

Estimated treatment difference, LS Mean53.2395% CI-26.30 – 132.76p0.2978ANCOVA

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) at Week 26

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) at Week 104

Time frame:week 0, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Time frame:week 0, week 104

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Time frame:week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Time frame:week 0, week 104

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Beta-cell Function at Week 26

Time frame:week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Beta-cell Function at Week 104

Time frame:week 0, week 104

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Hypoglycaemic Episodes at Week 26

Time frame:weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 0.6 + MetMajor	0	—
Minor	15	—
Symptoms only	17	—
Lira 1.2 + MetMajor	0	—
Minor	3	—
Symptoms only	7	—
Lira 1.8 + MetMajor	0	—
Minor	9	—
Symptoms only	22	—
Met MonoMajor	0	—
Minor	6	—
Symptoms only	10	—
Met + GlimMajor	0	—
Minor	136	—
Symptoms only	175	—

Secondary/registry result

Hypoglycaemic Episodes at Week 104

Time frame:weeks 0-104

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Lira 0.6 + MetAll	52	—
Major	0	—
Minor	23	—
Symptoms only	29	—
Lira 1.2 + MetAll	51	—
Major	1	—
Minor	26	—
Symptoms only	24	—
Lira 1.8 + MetAll	49	—
Major	0	—
Minor	22	—
Symptoms only	27	—
Met MonoAll	18	—
Major	0	—
Minor	6	—
Symptoms only	12	—
Met + GlimAll	524	—
Major	0	—
Minor	284	—
Symptoms only	240	—

Secondary/protocol endpoint

Hypoglycaemic Episodes at Week 26

Time frame:weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Hypoglycaemic Episodes at Week 104

Time frame:weeks 0-104

Documented hypoglycemia

event count, event

Publications (18)

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
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
Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study.
Diabetes, obesity & metabolism2013 Mar (month)PMID22985213doi:10.1111/dom.12012via 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
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
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
Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus.
Diabetic medicine : a journal of the British Diabetic Association2012 Mar (month)PMID21883438doi:10.1111/j.1464-5491.2011.03429.xvia 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
GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide.
The Journal of clinical endocrinology and metabolism2011 Mar (month)PMID21209033doi:10.1210/jc.2010-2318via clinicaltrials gov reference derived + 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
Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue.
Diabetes, obesity & metabolism2009 Dec (month)PMID19930006doi:10.1111/j.1463-1326.2009.01158.xvia CT.gov reference
Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits.
Postgraduate medicine2009 May (month)PMID19491535doi:10.3810/pgm.2009.05.1997via 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
Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study.
Diabetes care2009 Jan (month)PMID18931095doi:10.2337/dc08-1355via 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 tableClinicalTrials.gov results section

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.