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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

Short name LEAD-6

NCTNCT00518882 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1797Other id2006-006092-21
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
467 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
16 countries

United States, Austria, Denmark, Finland, France, Germany, Ireland, North Macedonia, Norway, Poland, Puerto Rico, Romania, Slovenia, Spain, Sweden, Switzerland

Start
Aug 2007
Primary completion
Apr 2008
Completion
Apr 2009
First posted
21 Aug 2007 (estimated)
Last update posted
8 Mar 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 3

    LEAD-6

    NCT00518882

    Aug 2007 to Apr 2009

Registry summary

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

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

Interventions

  • liraglutideDrug
  • exenatideDrug

Arms2

  • Experimental

    Liraglutide

    Liraglutide 1.8 mg once daily + subject's own OAD treatment

  • Active comparator

    Exenatide

    Exenatide 10 mcg twice daily + subject's own OAD treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated A1c (HbA1c) at Week 26

    Time frame · week 0, week 26

    Registry description

    Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)

Secondary outcomes(20)

  1. Change in Glycosylated A1c (HbA1c), Weeks 26-78

    Time frame · week 26, week 78

    Registry description

    Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

  2. Change in Glycosylated A1c (HbA1c) at Week 78

    Time frame · week 0, week 78

    Registry description

    Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

  3. Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26

    Time frame · week 0, week 26

    Registry description

    Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)

  4. Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78

    Time frame · week 0, week 78

    Registry description

    Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)

  5. Change in Body Weight at Week 26

    Time frame · week 0, week 26

    Registry description

    Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)

  6. Change in Body Weight, Weeks 26-78

    Time frame · week 26, week 78

    Registry description

    Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

  7. Change in Body Weight at Week 78

    Time frame · week 0, week 78

    Registry description

    Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

  8. Change in Fasting Plasma Glucose at Week 26

    Time frame · week 0, week 26

    Registry description

    Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)

  9. Change in Fasting Plasma Glucose, Weeks 26-78

    Time frame · week 26, week 78

    Registry description

    Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

  10. Change in Fasting Plasma Glucose at Week 78

    Time frame · week 0, week 78

    Registry description

    Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

  11. Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26

    Time frame · week 0, week 26

    Registry description

    Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.

  12. Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26

    Time frame · week 0, week 26

    Registry description

    Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

  13. Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26

    Time frame · week 0, week 26

    Registry description

    Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

  14. Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

    Time frame · week 26, week 78

    Registry description

    Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

  15. Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78

    Time frame · week 26, week 78

    Registry description

    Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.

  16. Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78

    Time frame · week 26, week 78

    Registry description

    Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

  17. Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78

    Time frame · week 0, week 78

    Registry description

    Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

  18. Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78

    Time frame · week 0, week 78

    Registry description

    Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

  19. Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78

    Time frame · week 0, week 78

    Registry description

    Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

  20. Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26

    Time frame · week 0, week 26

    Registry description

    Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

Posted results

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

Primary outcome results

Primary outcomeLeast squares mean· week 0, week 26

Change in Glycosylated A1c (HbA1c) at Week 26

GroupValue (percentage point of total HbA1c)Spread
Liraglutide -> Liraglutide -> Liraglutide-1.120.08
Exenatide -> Liraglutide -> Liraglutide-0.790.08
Secondary and other outcome results(7)
Secondary outcomeMean· week 26, week 78

Change in Glycosylated A1c (HbA1c), Weeks 26-78

GroupValue (percentage point of total HbA1c)Spread
Liraglutide -> Liraglutide -> Liraglutide0.250.803
Exenatide -> Liraglutide -> Liraglutide-0.000.924
Secondary outcomeMean· week 0, week 78

Change in Glycosylated A1c (HbA1c) at Week 78

GroupValue (percentage point of total HbA1c)Spread
Liraglutide -> Liraglutide -> Liraglutide-0.981.119
Exenatide -> Liraglutide -> Liraglutide-0.851.105
Secondary outcomeNumber· week 0, week 26

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26

GroupValue (percentage (%) of subjects)
Liraglutide -> Liraglutide -> Liraglutide53
Exenatide -> Liraglutide -> Liraglutide42
Secondary outcomeNumber· week 0, week 78

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78

GroupValue (percentage (%) of subjects)
Liraglutide -> Liraglutide -> Liraglutide47
Exenatide -> Liraglutide -> Liraglutide48
Secondary outcomeLeast squares mean· week 0, week 26

Change in Body Weight at Week 26

GroupValue (kg)Spread
Liraglutide -> Liraglutide -> Liraglutide-3.240.33
Exenatide -> Liraglutide -> Liraglutide-2.870.33
Secondary outcomeMean· week 26, week 78

Change in Body Weight, Weeks 26-78

GroupValue (kg)Spread
Liraglutide -> Liraglutide -> Liraglutide-0.43.24
Exenatide -> Liraglutide -> Liraglutide-0.73.67
Secondary outcomeMean· week 0, week 78

Change in Body Weight at Week 78

GroupValue (kg)Spread
Liraglutide -> Liraglutide -> Liraglutide-3.34.63
Exenatide -> Liraglutide -> Liraglutide-3.24.44

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide -> Liraglutide -> LiraglutideLiraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)–23 / 235162 / 235
Exenatide -> Liraglutide -> LiraglutideExenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)–23 / 232167 / 232

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies16

Studies that cite this trial.

Studies with results

11 studies on this page

Indexing hint: Meta-analysis (pooled) · 2016

6 results

Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials.

Davidson et al. 2016Diabetes, obesity & metabolismcited by 12

PMID 26936426DOI 10.1111/dom.12653PUB-26936426

Rights unknown6 results
Source linkSee results (6)

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 pageSee 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 pageSee 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 pageSee results (3)

Indexing hint: Randomized controlled trial · 2011

18 results

Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study.

Schmidt et al. 2011Diabetic medicine : a journal of the British Diabetic Associationcited by 25

PMID 21388442PMC3123703DOI 10.1111/j.1464-5491.2011.03276.xPUB-21388442

CC BY18 results
Download PDFSee results (18)

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 pageSee 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 pageSee 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 pageSee results (4)

Indexing hint: Randomized controlled trial · 2010

10 results

Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents.

Buse et al. 2010Diabetes carecited by 129

PMID 20332351PMC2875443DOI 10.2337/dc09-2260PUB-20332351

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

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 PDFSee results (10)

Indexing hint: Randomized controlled trial · 2009

16 results

Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6).

Buse et al. 2009Lancet (London, England)cited by 1,104

PMID 19515413DOI 10.1016/s0140-6736(09)60659-0PUB-19515413

Full text at the publisher16 results
Publisher pageSee results (16)

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 linkRead 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

PubMed tag: none · 2011

Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents.

Valentine et al. 2011Clinical therapeuticscited by 17

PMID 22018679DOI 10.1016/j.clinthera.2011.09.022PUB-22018679

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

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 * Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator * HbA1C equal to or greater than 7.0% and equal to or lower than 11.0% * Body Mass Index (BMI) equal to or lower than 45.0 kg/m2 Exclusion Criteria: * Previous treatment with insulin * Treatment with any anti-diabetic drug other than metformin and sulphonylurea * Any previous exposure to exenatide or liraglutide * Impaired liver or/and renal function * History of any significant cardiac events * Known retinopathy or maculopathy requiring acute treatment * Recurrent major hypoglycaemia or hypoglycaemic unawareness

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