Trial · Interventional

CompletedPhase 3Registry data

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

Short name LEAD-1

NCTNCT00318422Other idNN2211-1436Other id2005-003414-15Other id2005

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,041 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 23 countries
Argentina, Australia, Brazil, Bulgaria, Croatia, Czechia, Finland, France, Greece, India, Israel, Italy, Malaysia, Philippines, Poland, Romania, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye)
Start: May 2006
Primary completion: May 2007
Completion: May 2007
First posted: 26 Apr 2006 (estimated)
Last update posted: 25 Jan 2017 (estimated)
Conditions: Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200620072008

Ph 3
LEAD-1
NCT00318422
May 2006 to May 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

Interventions

liraglutideDrug
rosiglitazoneDrug
glimepirideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

HbA1c
Time frame · after 26 weeks of treatment

Secondary outcomes(4)

body weight
Safety and tolerability
beta-cell function
Glycemic control parameters (fasting plasma glucose, -glucose profiles)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies15

Studies that cite this trial.

Studies with results

10 studies on this page

Indexing hint: Randomized controlled trial · 2013

8 results

Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.

Niswender et al. 2013Diabetes, obesity & metabolismcited by 75

PMID 22862847DOI 10.1111/j.1463-1326.2012.01673.xPUB-22862847

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Meta-analysis (pooled) · 2012

3 results

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.

Zinman et al. 2012Diabetes, obesity & metabolismcited by 81

PMID 21883806DOI 10.1111/j.1463-1326.2011.01493.xPUB-21883806

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Meta-analysis (pooled) · 2012

3 results

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.

Alves et al. 2012Diabetes research and clinical practicecited by 142

PMID 23010561DOI 10.1016/j.diabres.2012.09.008PUB-23010561

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 2011

3 results

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.

Hegedüs et al. 2011The Journal of clinical endocrinology and metabolismcited by 150

PMID 21209033DOI 10.1210/jc.2010-2318PUB-21209033

Rights unknown3 results

Source link See results (3)

Indexing hint: Clinical trial · 2011

6 results

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.

Buse et al. 2011The Journal of clinical endocrinology and metabolismcited by 116

PMID 21450987DOI 10.1210/jc.2010-2822PUB-21450987

Full text at the publisher6 results

Publisher page See results (6)

Indexing hint: Observational study · 2011

8 results

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.

Bode et al. 2011The American journal of geriatric pharmacotherapycited by 43

PMID 22055210DOI 10.1016/j.amjopharm.2011.09.007PUB-22055210

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Meta-analysis (pooled) · 2011

4 results

Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program.

Henry et al. 2011Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 42

PMID 22193143DOI 10.4158/ep.17.6.906PUB-22193143

Full text at the publisher4 results

Publisher page See results (4)

Indexing hint: Clinical trial · 2009

10 results

Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone.

Sullivan et al. 2009Cardiovascular diabetologycited by 18

PMID 19245711PMC2667489DOI 10.1186/1475-2840-8-12PUB-19245711

CC BY10 results

Download PDF See results (10)

Indexing hint: Randomized controlled trial · 2009

13 results

Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU).

Marre et al. 2009Diabetic medicine : a journal of the British Diabetic Associationcited by 610

PMID 19317822PMC2871176DOI 10.1111/j.1464-5491.2009.02666.xPUB-19317822

CC BY13 results

Download PDF See results (13)

Indexing hint: Randomized controlled trial · 2009

6 results

Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits.

Nauck et al. 2009Postgraduate medicinecited by 25

PMID 19491535DOI 10.3810/pgm.2009.05.1997PUB-19491535

Full text at the publisher6 results

Publisher page See results (6)

More studies

5 studies on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

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.

Jensen et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

Rights unknown

Source link Read the notice

PubMed tag: none · 2014

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.

Fonseca et al. 2014Journal of diabetes and its complicationscited by 79

PMID 24561125PMC4231710DOI 10.1016/j.jdiacomp.2014.01.009PUB-24561125

Free to read · publisher termsCC BY-NC-ND

Read at source

PubMed tag: none · 2013

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%.

King et al. 2013Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 14

PMID 23186975DOI 10.4158/ep12232.orPUB-23186975

Full text at the publisher

Publisher page

Indexing hint: Review · 2009

Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies.

McGill et al. 2009Postgraduate medicinecited by 32

PMID 19491536DOI 10.3810/pgm.2009.05.1998PUB-19491536

Full text at the publisher

Publisher page

Indexing hint: Review · 2009

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.

Blonde et al. 2009Diabetes, obesity & metabolismcited by 165

PMID 19878259DOI 10.1111/j.1463-1326.2009.01075.xPUB-19878259

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Type 2 diabetes * Treatment with oral anti-diabetic drugs 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 to 45.0 kg/m2. Exclusion Criteria: * Treatment with insulin within the last three months * Treatment with any drug that could interfere with the glucose level * Any serious medical condition * Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

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