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DiabetesPhase 3LEAD-1NCT00318422

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

A Phase 3 study testing liraglutide, rosiglitazone and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 127 sites in 23 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 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. 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 glimepiride
How many people
1,041 participants
Where
127 sitesin 23 countries
Study dates
May 2006to May 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
  • 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.

Who cannot join

  • 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

Trial locations and contacts

127 sites in 23 countries.

127 sites in 23 countries

Poland15 sites

  • Novo Nordisk Investigational Site

    Bytom, 41-902

  • Novo Nordisk Investigational Site

    Gdansk, 80-858

  • Novo Nordisk Investigational Site

    Gniewkowo, 88-140

  • Novo Nordisk Investigational Site

    Kamieniec Ząbkowicki, 57-230

  • Novo Nordisk Investigational Site

    Krakow, 31-455

  • Novo Nordisk Investigational Site

    Lodz, 90-030

  • Novo Nordisk Investigational Site

    Lublin, 20-081

  • Novo Nordisk Investigational Site

    Lublin, 20-538

  • Novo Nordisk Investigational Site

    Mazowieckie, 09-400

  • Novo Nordisk Investigational Site

    Nysa, 48-300

  • Novo Nordisk Investigational Site

    Rawa Mazowiecka, 96-200

  • Novo Nordisk Investigational Site

    Szczecin, 71-455

  • Novo Nordisk Investigational Site

    Tychy, 43-100

  • Novo Nordisk Investigational Site

    Warsaw, 01-911

  • Novo Nordisk Investigational Site

    Zabrze, 41-800

Other trials in Poland

Finland10 sites

  • Novo Nordisk Investigational Site

    Espoo, 02740

  • Novo Nordisk Investigational Site

    Helsinki, 00150

  • Novo Nordisk Investigational Site

    Lahti, 15110

  • Novo Nordisk Investigational Site

    Nurmijärvi, 01900

  • Novo Nordisk Investigational Site

    Oulu, FI-90100

  • Novo Nordisk Investigational Site

    Pieksämäki, 76100

  • Novo Nordisk Investigational Site

    Rauma, 26100

  • Novo Nordisk Investigational Site

    Rovaniemi, 96100

  • Novo Nordisk Investigational Site

    Tampere, 33100

  • Novo Nordisk Investigational Site

    Tampere, 33101

Other trials in Finland

Australia9 sites

  • Novo Nordisk Investigational Site

    Caboolture, 4510

  • Novo Nordisk Investigational Site

    Ingleburn, 2565

  • Novo Nordisk Investigational Site

    Kippa-Ring, 4021

  • Novo Nordisk Investigational Site

    Melbourne, Victoria, 3004

  • Novo Nordisk Investigational Site

    Miranda, 2228

  • Novo Nordisk Investigational Site

    Randwick, 2031

  • Novo Nordisk Investigational Site

    Southport, 4215

  • Novo Nordisk Investigational Site

    Stones Corner, 4120

  • Novo Nordisk Investigational Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

France9 sites

  • Novo Nordisk Investigational Site

    Dax, 40107

  • Novo Nordisk Investigational Site

    La Rochelle, 17019

  • Novo Nordisk Investigational Site

    Montpellier, 34295

  • Novo Nordisk Investigational Site

    Mougins, 06250

  • Novo Nordisk Investigational Site

    Narbonne, 11108

  • Novo Nordisk Investigational Site

    Nevers, 58033

  • Novo Nordisk Investigational Site

    Paris, 75877

  • Novo Nordisk Investigational Site

    Rennes, 35056

  • Novo Nordisk Investigational Site

    Saint-Mandé, 94160

Other trials in France

Italy8 sites

  • Novo Nordisk Investigational Site

    Catania, 95122

  • Novo Nordisk Investigational Site

    Lucca, 55100

  • Novo Nordisk Investigational Site

    Milan, 20132

  • Novo Nordisk Investigational Site

    Naples, 80138

  • Novo Nordisk Investigational Site

    Perugia, 06126

  • Novo Nordisk Investigational Site

    Ravenna, 48121

  • Novo Nordisk Investigational Site

    Roma, 00189

  • Novo Nordisk Investigational Site

    Torino, 10144

Other trials in Italy

Czechia7 sites

  • Novo Nordisk Investigational Site

    Brno, 65691

  • Novo Nordisk Investigational Site

    Hradec Králové, 500 36

  • Novo Nordisk Investigational Site

    Ostrava, 70852

  • Novo Nordisk Investigational Site

    Plzen - Lochotin, 30460

  • Novo Nordisk Investigational Site

    Prague, 10034

  • Novo Nordisk Investigational Site

    Prague, 140 21

  • Novo Nordisk Investigational Site

    Prague, 15018

Other trials in Czechia

Argentina6 sites

  • Novo Nordisk Investigational Site

    Buenos Aires, B1636DSU

  • Novo Nordisk Investigational Site

    Buenos Aires, C1181ACH

  • Novo Nordisk Investigational Site

    Buenos Aires, C1425AGC

  • Novo Nordisk Investigational Site

    Córdoba, 5000

  • Novo Nordisk Investigational Site

    Mar del Plata, B7602CBM

  • Novo Nordisk Investigational Site

    Mendoza, 5500

Other trials in Argentina

Bulgaria6 sites

  • Novo Nordisk Investigational Site

    Pleven, 5800

  • Novo Nordisk Investigational Site

    Plovdiv, 4002

  • Novo Nordisk Investigational Site

    Rousse, 7000

  • Novo Nordisk Investigational Site

    Sofia, 1431

  • Novo Nordisk Investigational Site

    Sofia, 1606

  • Novo Nordisk Investigational Site

    Varna, 9010

Other trials in Bulgaria

Turkey (Türkiye)6 sites

  • Novo Nordisk Investigational Site

    Ankara, 06500

  • Novo Nordisk Investigational Site

    Antalya, 07059

  • Novo Nordisk Investigational Site

    Istanbul, 34390

  • Novo Nordisk Investigational Site

    Istanbul, 34718

  • Novo Nordisk Investigational Site

    Istanbul, 34890

  • Novo Nordisk Investigational Site

    Izmir, 35340

Other trials in Turkey (Türkiye)

Romania5 sites

  • Novo Nordisk Investigational Site

    Baia Mare, 430032

  • Novo Nordisk Investigational Site

    Brasov, Brașov County, 500269

  • Novo Nordisk Investigational Site

    Bucharest, 020475

  • Novo Nordisk Investigational Site

    Ploieşti, Prahova, 100097

  • Novo Nordisk Investigational Site

    Timișoara, 300736

Other trials in Romania

South Africa5 sites

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1829

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2001

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2076

  • Novo Nordisk Investigational Site

    Umhlanga, 4320

Other trials in South Africa

Switzerland5 sites

  • Novo Nordisk Investigational Site

    Bern, 3010

  • Novo Nordisk Investigational Site

    Lausanne, 1011

  • Novo Nordisk Investigational Site

    Sankt Gallen, 9007

  • Novo Nordisk Investigational Site

    Zurich, 8032

  • Novo Nordisk Investigational Site

    Zurich, 8091

Other trials in Switzerland

Greece4 sites

  • Novo Nordisk Investigational Site

    Athens, 115 21

  • Novo Nordisk Investigational Site

    Athens, 151 23

  • Novo Nordisk Investigational Site

    Athens, GR-10552

  • Novo Nordisk Investigational Site

    Athens, GR-11527

Other trials in Greece

India4 sites

  • Novo Nordisk Investigational Site

    Chandigarh, Punjab, 160012

  • Novo Nordisk Investigational Site

    Chennai, 600116

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 4000021

  • Novo Nordisk Investigational Site

    Mumbai, 400 0067

Other trials in India

Philippines4 sites

  • Novo Nordisk Investigational Site

    Davao City, 8000

  • Novo Nordisk Investigational Site

    Makati City, 1218

  • Novo Nordisk Investigational Site

    Marikina City, 1100

  • Novo Nordisk Investigational Site

    Quezon City, 1100

Other trials in Philippines

Taiwan4 sites

  • Novo Nordisk Investigational Site

    Changhua, 500

  • Novo Nordisk Investigational Site

    Kaohsiung City, 833

  • Novo Nordisk Investigational Site

    Taipei, 100

  • Novo Nordisk Investigational Site

    Taipei, 231

Other trials in Taiwan

Croatia3 sites

  • Novo Nordisk Investigational Site

    Osijek, 31 000

  • Novo Nordisk Investigational Site

    Slavonski Brod, 35 000

  • Novo Nordisk Investigational Site

    Split, 21 000

Other trials in Croatia

Israel3 sites

  • Novo Nordisk Investigational Site

    Haifa, 31096

  • Novo Nordisk Investigational Site

    Jerusalem, 91120

  • Novo Nordisk Investigational Site

    Tel HaShomer, 52621

Other trials in Israel

Malaysia3 sites

  • Novo Nordisk Investigational Site

    Cheras, 56000

  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan, 16150

  • Novo Nordisk Investigational Site

    Pulau Pinang, 10990

Other trials in Malaysia

South Korea3 sites

  • Novo Nordisk Investigational Site

    Seoul, 08308

  • Novo Nordisk Investigational Site

    Seoul, 130-701

  • Novo Nordisk Investigational Site

    Seoul, 137-701

Other trials in South Korea

Spain3 sites

  • Novo Nordisk Investigational Site

    Gijón, 33206

  • Novo Nordisk Investigational Site

    Palma de Mallorca, 07198

  • Novo Nordisk Investigational Site

    Reus, 43201

Other trials in Spain

Thailand3 sites

  • Novo Nordisk Investigational Site

    Bangkok, 10110

  • Novo Nordisk Investigational Site

    Bangkok, 10330

  • Novo Nordisk Investigational Site

    Bangkok, 10400

Other trials in Thailand

Brazil2 sites

  • Novo Nordisk Investigational Site

    Fortaleza, 60120-021

  • Novo Nordisk Investigational Site

    São Paulo, 04022-001

Other trials in Brazil

About this study

Official title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

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.

Being tested
liraglutide, rosiglitazone, glimepiride
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 (4)

  1. body weight

  2. Safety and tolerability

  3. beta-cell function

  4. Glycemic control parameters (fasting plasma glucose, -glucose profiles)

Timeline

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

  1. First posted26 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMay 2007
  4. Study completionMay 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
1,041 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00318422
Sponsor's protocol ID
NN2211-1436
Other IDs
2005-003414-15, 2005
Acronym
LEAD-1
Status last verified
Jan 2017
First submitted
25 Apr 2006
Last updated
25 Jan 2017
Results posted
No
Data monitoring committee
No

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

  • Marre M, Shaw J, Brandle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. 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). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.

    PubMed 19317822

  • Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.

    PubMed 19491535

  • 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

  • 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

  • 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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide, rosiglitazone and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 127 sites in 23 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 4 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 127 sites in Poland, Finland, Australia, France, Italy and 18 more countries. 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 NCT00318422, 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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