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DiabetesPhase 3LEAD-4NCT00333151

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

A Phase 3 study testing liraglutide, rosiglitazone and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 89 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
liraglutide, rosiglitazone and metformin
How many people
576 participants
Where
89 sitesin 2 countries
Study dates
May 2006to Aug 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes
  • Treated with oral anti-diabetic (OAD) drugs for at least 3 months
  • Treated with one or more OAD and in moderate to poor glycemic control
  • Body Mass Index (BMI) less than or equal to 45.0 kg/m2

Who cannot join

  • Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator
  • Any serious medical condition
  • Treatment with any drug that could interfere with glucose level

Trial locations and contacts

89 sites in 2 countries.

89 sites in 2 countries

United States71 sites

  • Novo Nordisk Investigational Site

    Albany, New York, 12206

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76014

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28803

  • Novo Nordisk Investigational Site

    Athens, Georgia, 30606

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30032

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30034

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30318

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana, 70808

  • Novo Nordisk Investigational Site

    Berlin, New Jersey, 08009

  • Novo Nordisk Investigational Site

    Brooklyn, New York, 11203

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27599-7172

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45245

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44195

  • Novo Nordisk Investigational Site

    Colton, California, 92324

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43203

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43212

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-8858

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45406

  • Novo Nordisk Investigational Site

    Des Moines, Iowa, 50314

  • Novo Nordisk Investigational Site

    Duncan, South Carolina, 29334

  • Novo Nordisk Investigational Site

    Durham, North Carolina, 27710

  • Novo Nordisk Investigational Site

    Escondido, California, 92025

  • Novo Nordisk Investigational Site

    Fort Myers, Florida, 33907

  • Novo Nordisk Investigational Site

    Goodyear, Arizona, 85395

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Houston, Texas, 77025

  • Novo Nordisk Investigational Site

    Houston, Texas, 77030

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Idaho Falls, Idaho, 83404-7596

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32204

  • Novo Nordisk Investigational Site

    Kettering, Ohio, 45429

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Lake Mary, Florida, 32746

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Long Beach, California, 90822

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90024

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Lubbock, Texas, 79430-8183

  • Novo Nordisk Investigational Site

    Mentor, Ohio, 44060

  • Novo Nordisk Investigational Site

    Midland, Texas, 79707

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Mission Viejo, California, 92691

  • Novo Nordisk Investigational Site

    New Albany, Indiana, 47150

  • Novo Nordisk Investigational Site

    New Britain, Connecticut, 06050

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70121

  • Novo Nordisk Investigational Site

    Newport News, Virginia, 23606

  • Novo Nordisk Investigational Site

    Northport, New York, 11768

  • Novo Nordisk Investigational Site

    Orange, California, 92869

  • Novo Nordisk Investigational Site

    Peoria, Illinois, 61615

  • Novo Nordisk Investigational Site

    Plainsboro, New Jersey, 08536

  • Novo Nordisk Investigational Site

    Plantation, Florida, 33324

  • Novo Nordisk Investigational Site

    Powder Springs, Georgia, 30127

  • Novo Nordisk Investigational Site

    Reno, Nevada, 89502

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23294

  • Novo Nordisk Investigational Site

    Rochester, New York, 14621

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84102

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78209

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    Santa Ana, California, 92705

  • Novo Nordisk Investigational Site

    Santa Barbara, California, 93105

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99218

  • Novo Nordisk Investigational Site

    Spring Valley, California, 91978

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63110

  • Novo Nordisk Investigational Site

    Topeka, Kansas, 66606

  • Novo Nordisk Investigational Site

    Tupelo, Mississippi, 38801

  • Novo Nordisk Investigational Site

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada18 sites

  • Novo Nordisk Investigational Site

    Calgary, Alberta, T2H 2G4

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T5J 3N4

  • Novo Nordisk Investigational Site

    Gatineau, J8T 8M1

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Novo Nordisk Investigational Site

    Laval, Quebec, H7T 2P5

  • Novo Nordisk Investigational Site

    London, Ontario, N6A 4V2

  • Novo Nordisk Investigational Site

    Mississauga, L5M 2V8

  • Novo Nordisk Investigational Site

    Montreal, H2W 1R7

  • Novo Nordisk Investigational Site

    Montreal, H3A 1A1

  • Novo Nordisk Investigational Site

    Ottawa, Ontario, K1N 6N5

  • Novo Nordisk Investigational Site

    Québec, G1V 4G2

  • Novo Nordisk Investigational Site

    Red Deer, T4N 6V7

  • Novo Nordisk Investigational Site

    St. John's, A1B 3V6

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M5C 2T2

  • Novo Nordisk Investigational Site

    Toronto, M5G 1X5

  • Novo Nordisk Investigational Site

    Vancouver, V5Z 1C6

  • Novo Nordisk Investigational Site

    Windsor, N8W 3K2

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

Official title: Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

Being tested
liraglutide, rosiglitazone, metformin
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: after 26 weeks of treatment

Secondary outcomes (3)

  1. body weight

  2. Safety and tolerability

  3. Glycaemic control

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00333151
Sponsor's protocol ID
NN2211-1574
Acronym
LEAD-4
Status last verified
Jan 2017
First submitted
1 Jun 2006
Last updated
25 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. 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. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

    PubMed 21450987

  • Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

    PubMed 19245711

  • Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224-30. doi: 10.2337/dc08-2124. Epub 2009 Mar 16.

    PubMed 19289857

  • McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.

    PubMed 19491536

  • Blonde L, Russell-Jones D. 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 Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.

    PubMed 19878259

  • Bode BW, Brett J, Falahati A, Pratley RE. 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. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

    PubMed 22055210

  • Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.

    PubMed 22193143

  • Zinman B, Schmidt WE, Moses A, Lund N, Gough S. 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 Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

    PubMed 21883806

  • Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

    PubMed 22862847

  • Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

    PubMed 23010561

  • King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. 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%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

    PubMed 23186975

  • Jensen TM, Saha K, Steinberg WM. 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 Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.

    PubMed 25504028

  • Davidson JA, Orsted DD, Campos C. 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. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.

    PubMed 26936426

  • Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. 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. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

    PubMed 24561125

  • Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. 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. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.

    PubMed 21209033

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide, rosiglitazone and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 89 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: after 26 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00333151, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.

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