Clinical trial NCT00700817: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
Official title: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
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: 2008-06-19
Enrollment: 665
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 and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

1. Week 27-52 after randomisation

   - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
2. Week 53-78 after randomisation

   * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
   * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Treatment with metformin alone for at least three months
* HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
* Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

* Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
* Treatment with anti-diabetic drugs other than metformin within the last three months
* Any serious medical condition
* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Primary outcomes:
measure: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
timeFrame: Week 0, Week 78
measure: Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
timeFrame: Week 52, Week 78
Secondary outcomes:
measure: Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
timeFrame: Week 0, Week 26
measure: Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
timeFrame: Week 0, Week 52
measure: Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
timeFrame: Week 0, Week 78
measure: Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
timeFrame: Week 0, Week 78
measure: Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
timeFrame: Week 0, Week 26
measure: Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
timeFrame: Week 0, Week 52
measure: Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
timeFrame: Week 0, Week 78
measure: Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
timeFrame: Week 0, Week 78
measure: Mean Change From Baseline in Body Weight at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Body Weight at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Body Weight From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
timeFrame: Week 0, Week 78
measure: Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Beta-cell Function at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Beta-cell Function at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Beta-cell Function From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Total Cholesterol at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Total Cholesterol at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Total Cholesterol From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Triglycerides (TG) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Triglycerides (TG) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Triglycerides (TG) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Apolipoprotein B at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Apolipoprotein B at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Apolipoprotein B From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Adiponectin at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Waist to Hip Ratio at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Waist to Hip Ratio at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Waist to Hip Ratio From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Waist Circumference at Week 26.
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Waist Circumference at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Waist Circumference From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Pulse at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Pulse at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Pulse From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
timeFrame: Week 0, Week 26
measure: Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
timeFrame: Week 52, Week 78
measure: Hypoglyceamic Episodes, Weeks 0-26
timeFrame: Weeks 0-26
measure: Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
timeFrame: Weeks 0-26
measure: Hypoglyceamic Episodes, Weeks 0-52
timeFrame: Weeks 0-52
measure: Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
timeFrame: Weeks 0-52
measure: Hypoglyceamic Episodes, Weeks 0-78
timeFrame: Weeks 0-78
measure: Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
timeFrame: Weeks 0-78
measure: Hypoglycaamic Episodes, Weeks 52-78
timeFrame: Week 52-78
Other outcomes:
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country: United States
facility: Novo Nordisk Investigational Site
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city: Huntington Beach
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city: Northridge
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state: California
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state: Colorado
city: Crystal River
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state: Florida
city: Jacksonville
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state: Florida
city: Miami
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state: Florida
city: Ocala
country: United States
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state: Florida
city: Panama City
country: United States
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state: Florida
city: St. Cloud
country: United States
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state: Florida
city: Athens
country: United States
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state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Dunwoody
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state: Georgia
city: Lithia Springs
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state: Georgia
city: Honolulu
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state: Hawaii
city: Boise
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state: Idaho
city: Chicago
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state: Illinois
city: Shawnee Mission
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state: Kansas
city: Metairie
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state: Louisiana
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state: Maryland
city: Minneapolis
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state: Minnesota
city: Cleveland
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state: Mississippi
city: St. Peters
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state: Missouri
city: Las Vegas
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state: Nevada
city: Berlin
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city: Northport
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state: New York
city: Rosedale
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city: Pinehurst
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city: Tabor City
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state: North Carolina
city: Cincinnati
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city: Columbus
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city: Cuyahoga Falls
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state: Ohio
city: Dayton
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state: Ohio
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state: Ohio
city: Mentor
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state: Ohio
city: Eugene
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state: Oregon
city: Altoona
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state: Pennsylvania
city: Norristown
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state: Pennsylvania
city: Kingsport
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state: Tennessee
city: Arlington
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state: Texas
city: Dallas
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
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state: Texas
city: Hurst
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: St. George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: South Burlington
country: United States
facility: Novo Nordisk Investigational Site
state: Vermont
city: Newport News
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
city: Karlovac
country: Croatia
facility: Novo Nordisk Investigational Site
city: Sisak
country: Croatia
facility: Novo Nordisk Investigational Site
city: Slavonski Brod
country: Croatia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: Nis
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: LA ROCHE-sur-YON cedex 9
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Limoges
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Saint Mandé
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bochum
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Herrenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Kassel
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Riesa
country: Germany
facility: Novo Nordisk Investigational Site
city: Schönebeck
country: Germany
facility: Novo Nordisk Investigational Site
city: Ulm
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Wangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Dublin 9
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: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Lucca
country: Italy
facility: Novo Nordisk Investigational Site
city: Messina
country: Italy
facility: Novo Nordisk Investigational Site
city: Olbia
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
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city: Pavia
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Siena
country: Italy
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city: Trieste
country: Italy
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city: Almere
country: Netherlands
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city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Beek
country: Netherlands
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city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hengelo
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Leiden
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Stadskanaal
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zevenaar
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zoetermeer
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Caquas
country: Puerto Rico
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city: Guaynabo
country: Puerto Rico
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city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Rio Piedras
country: Puerto Rico
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city: Trujillo Alto
country: Puerto Rico
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city: Oradea
country: Romania
facility: Novo Nordisk Investigational Site
state: Bihor
city: Craiova
country: Romania
facility: Novo Nordisk Investigational Site
state: Dolj
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
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: Nitra
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nove Zamky
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Novo mesto
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Trbovlje
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Alzira
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Getafe
country: Spain
facility: Novo Nordisk Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Oviedo
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Puerto del Rosario
country: Spain
facility: Novo Nordisk Investigational Site
city: Aberdeen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Abergavenny
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Aldershot
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ayr
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chippenham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Letchworth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Maidstone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Salford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
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: Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8.
citation: Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x.
citation: Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1.
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.
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