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CompletedNCT00331851LEAD-5Updated Jan 26, 2017

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

A Phase 3 interventional study of liraglutide and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 116 sites in 18 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
584
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 584 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
584 participants (actual)
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. body weight

  2. Safety and tolerability

  3. Beta-cell function

  4. Glycaemic control

07

Study locations

116 sites
  • Novo Nordisk Investigational Site
    Bahía Blanca, 8000, Argentina
  • Novo Nordisk Investigational Site
    Ciudad Autonoma de Bs As, C1405CWB, Argentina
  • Novo Nordisk Investigational Site
    Junín, 6000, Argentina
  • Novo Nordisk Investigational Site
    Mendoza, 5500, Argentina
  • Novo Nordisk Investigational Site
    Rosario, 2000, Argentina
  • Novo Nordisk Investigational Site
    Bregenz, A - 6900, Austria
  • Novo Nordisk Investigational Site
    Vienna, 1010, Austria
  • Novo Nordisk Investigational Site
    Vienna, 1030, Austria
  • Novo Nordisk Investigational Site
    Vienna, 1120, Austria
  • Novo Nordisk Investigational Site
    Vienna, 1130, Austria
  • Novo Nordisk Investigational Site
    Vienna, 1230, Austria
  • Novo Nordisk Investigational Site
    Vienna, A 1090, Austria
  • Novo Nordisk Investigational Site
    Curitiba, 80810-040, Brazil
  • Novo Nordisk Investigational Site
    Rio de Janeiro, 20211-340, Brazil
  • Novo Nordisk Investigational Site
    Rio de Janeiro, 21941-590, Brazil
  • Novo Nordisk Investigational Site
    São Paulo, 05403-000, Brazil
  • Novo Nordisk Investigational Site
    São Paulo, 11060-001, Brazil
  • Novo Nordisk Investigational Site
    São Paulo, 80540-010, Brazil
  • Novo Nordisk Investigational Site
    Århus C, 8000, Denmark
  • Novo Nordisk Investigational Site
    Esbjerg, 6700, Denmark
  • Novo Nordisk Investigational Site
    Gentofte Municipality, 2820, Denmark
  • Novo Nordisk Investigational Site
    Hellerup, 2900, Denmark
  • Novo Nordisk Investigational Site
    Hillerød, 3400, Denmark
  • Novo Nordisk Investigational Site
    Roskilde, 4000, Denmark
  • Novo Nordisk Investigational Site
    Slagelse, 4200, Denmark
  • Novo Nordisk Investigational Site
    Helsinki, 00250, Finland
  • Novo Nordisk Investigational Site
    Helsinki, 00260, Finland
  • Novo Nordisk Investigational Site
    Kuopio, 70210, Finland
  • Novo Nordisk Investigational Site
    Oulu, FI-90220, Finland
  • Novo Nordisk Investigational Site
    Turku, 20700, Finland
  • Novo Nordisk Investigational Site
    Besançon, 25030, France
  • Novo Nordisk Investigational Site
    Brest, 29200, France
  • Novo Nordisk Investigational Site
    Corbeil-Essonnes, 91106, France
  • Novo Nordisk Investigational Site
    Dijon, 21079, France
  • Novo Nordisk Investigational Site
    La Rochelle, 17019, France
  • Novo Nordisk Investigational Site
    Nanterre, 92014, France
  • Novo Nordisk Investigational Site
    Narbonne, 11108, France
  • Novo Nordisk Investigational Site
    Nevers, 58033, France
  • Novo Nordisk Investigational Site
    Vénissieux, 69200, France
  • Novo Nordisk Investigational Site
    Hyderabad, Andhra Pradesh 500034, India
  • Novo Nordisk Investigational Site
    Karnāl, Haryana 132001, India
  • Novo Nordisk Investigational Site
    Pune, Maharashtra 411 037, India
  • Novo Nordisk Investigational Site
    Hyderabad, 600034, India
  • Novo Nordisk Investigational Site
    Patna, 800020, India
  • Novo Nordisk Investigational Site
    Bergamo, 24127, Italy
  • Novo Nordisk Investigational Site
    Bologna, 40133, Italy
  • Novo Nordisk Investigational Site
    Catania, 95124, Italy
  • Novo Nordisk Investigational Site
    Catanzaro, 88100, Italy
  • Novo Nordisk Investigational Site
    Chieri, 10023, Italy
  • Novo Nordisk Investigational Site
    Chieti Scalo, 66100, Italy
  • Novo Nordisk Investigational Site
    Messina, 98123, Italy
  • Novo Nordisk Investigational Site
    Padova, 35143, Italy
  • Novo Nordisk Investigational Site
    Parma, 43100, Italy
  • Novo Nordisk Investigational Site
    Siena, 53100, Italy
  • Novo Nordisk Investigational Site
    Almere Stad, 1311RL, Netherlands
  • Novo Nordisk Investigational Site
    Den Helder, 1782 GZ, Netherlands
  • Novo Nordisk Investigational Site
    Eindhoven, 5631 BM, Netherlands
  • Novo Nordisk Investigational Site
    Gouda, 2803HH, Netherlands
  • Novo Nordisk Investigational Site
    Maastricht, 6229 HX, Netherlands
  • Novo Nordisk Investigational Site
    The Hague, 2512 VA, Netherlands
  • Novo Nordisk Investigational Site
    Zevenaar, 6903 ZN, Netherlands
  • Novo Nordisk Investigational Site
    Zoetermeer, 2725 NA, Netherlands
  • Novo Nordisk Investigational Site
    Bergen, 5021, Norway
  • Novo Nordisk Investigational Site
    Gjettum, 1346, Norway
  • Novo Nordisk Investigational Site
    Jessheim, 2050, Norway
  • Novo Nordisk Investigational Site
    Nordbyhagen, 1474, Norway
  • Novo Nordisk Investigational Site
    Notodden, 3675, Norway
  • Novo Nordisk Investigational Site
    Sandvika, NO-1337, Norway
  • Novo Nordisk Investigational Site
    Skedsmokorset, NO-2020, Norway
  • Novo Nordisk Investigational Site
    Cebu City, 6000, Philippines
  • Novo Nordisk Investigational Site
    Manila, 1000, Philippines
  • Novo Nordisk Investigational Site
    Marikina City, 1810, Philippines
  • Novo Nordisk Investigational Site
    Pasig, 1605, Philippines
  • Novo Nordisk Investigational Site
    Gdynia, 81-366, Poland
  • Novo Nordisk Investigational Site
    Katowice, 40-053, Poland
  • Novo Nordisk Investigational Site
    Opole, 45-418, Poland
  • Novo Nordisk Investigational Site
    Poznan, 60-821, Poland
  • Novo Nordisk Investigational Site
    Wroclaw, 50-127, Poland
  • Novo Nordisk Investigational Site
    Zabrze, 41-800, Poland
  • Novo Nordisk Investigational Site
    Moscow, 117036, Russia
  • Novo Nordisk Investigational Site
    Moscow, 123448, Russia
  • Novo Nordisk Investigational Site
    Moscow, 127644, Russia
  • Novo Nordisk Investigational Site
    Belgrade, 11000, Serbia and Montenegro
  • Novo Nordisk Investigational Site
    Nis, 18000, Serbia and Montenegro
  • Novo Nordisk Investigational Site
    Banská Bystrica, 95717, Slovakia
  • Novo Nordisk Investigational Site
    Bratislava, 811 08, Slovakia
  • Novo Nordisk Investigational Site
    L'ubochna, 03491, Slovakia
  • Novo Nordisk Investigational Site
    Martin, 036 59, Slovakia
  • Novo Nordisk Investigational Site
    Nitra, 94 911, Slovakia
  • Novo Nordisk Investigational Site
    Žilina, 01001, Slovakia
  • Novo Nordisk Investigational Site
    Bloemfontein, Free State 6850, South Africa
  • Novo Nordisk Investigational Site
    Pretoria, Gauteng 0001, South Africa
  • Novo Nordisk Investigational Site
    Pretoria, Gauteng 0181, South Africa
  • Novo Nordisk Investigational Site
    Worcester, Western Cape 6850, South Africa
  • Novo Nordisk Investigational Site
    Barakaldo, 48903, Spain
  • Novo Nordisk Investigational Site
    Barcelona, 08035, Spain
  • Novo Nordisk Investigational Site
    Getafe, 28905, Spain
  • Novo Nordisk Investigational Site
    Málaga, 29009, Spain
  • Novo Nordisk Investigational Site
    Santiago de Compostela, 15706, Spain
  • Novo Nordisk Investigational Site
    Seville, 41014, Spain

Showing the first 100 of 116 sites across 18 countries.

08

References and documents

Publications

  • 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 ↗
  • 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 ↗
  • Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. 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. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14. PubMed 19688338 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • Buse JB, Peters A, Russell-Jones D, Furber S, Donsmark M, Han J, MacConell L, Maggs D, Diamant M. Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes Obes Metab. 2015 Feb;17(2):145-51. doi: 10.1111/dom.12402. Epub 2014 Nov 9. PubMed 25323312 ↗
  • 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 ↗
  • 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00331851
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
May 31, 2006
Start date
May 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Jan 26, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Liraglutide · Insulin Glargine · Metformin · Glimepiride

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