Clinical trial NCT00318461: To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Official title: Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-04-26
Enrollment: 1091
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) 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 40 kg/m2

Exclusion Criteria:

* Subjects treated with insulin within the last three months
* Subjects with any serious medical condition
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
* Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

Primary outcomes:
measure: Change in Glycosylated A1c (HbA1c) at Week 26
timeFrame: week 0, week 26
measure: Change in Glycosylated A1c (HbA1c) at Week 104
timeFrame: week 0, week 104
Secondary outcomes:
measure: Change in Body Weight at Week 26
timeFrame: week 0, week 26
measure: Change in Body Weight at Week 104
timeFrame: week 0, week 104
measure: Change in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: week 0, week 26
measure: Change in Fasting Plasma Glucose (FPG) at Week 104
timeFrame: week 0, week 104
measure: Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
timeFrame: week 0, week 26
measure: Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
timeFrame: week 0, week 104
measure: Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
timeFrame: week 0, week 26
measure: Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
timeFrame: week 0, week 104
measure: Change in Beta-cell Function at Week 26
timeFrame: week 0, week 26
measure: Change in Beta-cell Function at Week 104
timeFrame: week 0, week 104
measure: Hypoglycaemic Episodes at Week 26
timeFrame: weeks 0-26
measure: Hypoglycaemic Episodes at Week 104
timeFrame: weeks 0-104
Other outcomes:
Locations:
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad Autónoma de Bs As
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad Autónoma de BsAs
country: Argentina
facility: Novo Nordisk Investigational Site
city: Junín
country: Argentina
facility: Novo Nordisk Investigational Site
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Penrith
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Daw Park
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: East Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Novo Nordisk Investigational Site
state: Western Australia
city: Adelaide
country: Australia
facility: Novo Nordisk Investigational Site
city: Adelaide
country: Australia
facility: Novo Nordisk Investigational Site
city: Auckland
country: Australia
facility: Novo Nordisk Investigational Site
city: Bankstown
country: Australia
facility: Novo Nordisk Investigational Site
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
city: Cairns
country: Australia
facility: Novo Nordisk Investigational Site
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
city: Christchurch
country: Australia
facility: Novo Nordisk Investigational Site
city: Clayton
country: Australia
facility: Novo Nordisk Investigational Site
city: Fitzroy
country: Australia
facility: Novo Nordisk Investigational Site
city: Garran
country: Australia
facility: Novo Nordisk Investigational Site
city: Hornsby
country: Australia
facility: Novo Nordisk Investigational Site
city: Malvern
country: Australia
facility: Novo Nordisk Investigational Site
city: Perth
country: Australia
facility: Novo Nordisk Investigational Site
city: Westmead
country: Australia
facility: Novo Nordisk Investigational Site
city: Woodville
country: Australia
facility: Novo Nordisk Investigational Site
city: Arlon
country: Belgium
facility: Novo Nordisk Investigational Site
city: Bonheiden
country: Belgium
facility: Novo Nordisk Investigational Site
city: Gent
country: Belgium
facility: Novo Nordisk Investigational Site
city: Huy
country: Belgium
facility: Novo Nordisk Investigational Site
city: La Louvière
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Aalborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Frederiksberg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Herlev
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hjørring
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
city: København S
country: Denmark
facility: Novo Nordisk Investigational Site
city: København
country: Denmark
facility: Novo Nordisk Investigational Site
city: Odense
country: Denmark
facility: Novo Nordisk Investigational Site
city: Viborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Heilbrunn
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: Novo Nordisk Investigational Site
city: Beckum
country: Germany
facility: Novo Nordisk Investigational Site
city: Bensheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Darmstadt
country: Germany
facility: Novo Nordisk Investigational Site
city: Diez
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Flensburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Großheirath
country: Germany
facility: Novo Nordisk Investigational Site
city: Halle
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Kutenholz-Mulsum
country: Germany
facility: Novo Nordisk Investigational Site
city: Köln
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: Oberhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Pirna
country: Germany
facility: Novo Nordisk Investigational Site
city: Pohlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Regensburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saaldorf-Surheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Saarbrücken
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Tübingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Viersen
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Gyula
country: Hungary
facility: Novo Nordisk Investigational Site
city: Nyíregyháza
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pecs
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szekszárd
country: Hungary
facility: Novo Nordisk Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Kochi
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Waterford
country: Ireland
facility: Novo Nordisk Investigational Site
city: Bari
country: Italy
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Monza
country: Italy
facility: Novo Nordisk Investigational Site
city: Orbassano
country: Italy
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
facility: Novo Nordisk Investigational Site
city: Rimini
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Sassari
country: Italy
facility: Novo Nordisk Investigational Site
city: Torino
country: Italy
facility: Novo Nordisk Investigational Site
city: Verona
country: Italy
facility: Novo Nordisk Investigational Site
city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Sliedrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Bekkestua
country: Norway
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Elverum
country: Norway
facility: Novo Nordisk Investigational Site
city: Gjøvik
country: Norway
facility: Novo Nordisk Investigational Site
city: Hamar
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsberg
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsvinger
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Tromsø
country: Norway
facility: Novo Nordisk Investigational Site
city: Trondheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Cluj Napoca
country: Romania
facility: Novo Nordisk Investigational Site
state: Cluj
city: Constanta
country: Romania
facility: Novo Nordisk Investigational Site
city: Iasi
country: Romania
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Moldava nad Bodvou
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Presov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Trencin
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Benoni
country: South Africa
facility: Novo Nordisk Investigational Site
city: Alcazar de San Juan
country: Spain
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Bilbao
country: Spain
facility: Novo Nordisk Investigational Site
city: Cádiz
country: Spain
facility: Novo Nordisk Investigational Site
city: Girona
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: La Coruña
country: Spain
facility: Novo Nordisk Investigational Site
city: La Laguna
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Mérida
country: Spain
facility: Novo Nordisk Investigational Site
city: San Juan
country: Spain
facility: Novo Nordisk Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Falun
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Umeå
country: Sweden
facility: Novo Nordisk Investigational Site
city: Abergavenny
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Berkshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cardiff
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: East Horsley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Frome
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Llanelli
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sunbury on Thames
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.
citation: Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013 Mar;15(3):204-12. doi: 10.1111/dom.12012. Epub 2012 Oct 11.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.