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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00318422




Registration number
NCT00318422
Ethics application status
Date submitted
25/04/2006
Date registered
26/04/2006
Date last updated
25/01/2017

Titles & IDs
Public title
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Scientific 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.
Secondary ID [1] 0 0
2005-003414-15
Secondary ID [2] 0 0
NN2211-1436
Universal Trial Number (UTN)
Trial acronym
LEAD-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
after 26 weeks of treatment
Secondary outcome [1] 0 0
body weight
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Safety and tolerability
Timepoint [2] 0 0
Secondary outcome [3] 0 0
beta-cell function
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Glycemic control parameters (fasting plasma glucose, -glucose profiles)
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
1041
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Woolloongabba
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Caboolture
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Ingleburn
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Miranda
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Randwick
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Southport
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - Stones Corner
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
4510 - Caboolture
Recruitment postcode(s) [4] 0 0
2565 - Ingleburn
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
2228 - Miranda
Recruitment postcode(s) [7] 0 0
2031 - Randwick
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
4120 - Stones Corner
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
State/province [2] 0 0
Córdoba
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Argentina
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Mar del Plata
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Argentina
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Mendoza
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Brazil
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Fortaleza
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Brazil
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Sao Paulo
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Bulgaria
State/province [7] 0 0
Pleven
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Bulgaria
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Plovdiv
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Bulgaria
State/province [9] 0 0
Russe
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Croatia
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Osijek
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Croatia
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Slavonski Brod
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Croatia
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Split
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Czech Republic
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Brno
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Czech Republic
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Hradec Králové
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Czech Republic
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Ostrava
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Czech Republic
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Plzen - Lochotin
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Czech Republic
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Prague 4
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Czech Republic
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Praha 10
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Czech Republic
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Praha 5
Country [22] 0 0
Finland
State/province [22] 0 0
Espoo
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Finland
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Helsinki
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Finland
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Lahti
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Finland
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Nurmijärvi
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Finland
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Oulu
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Finland
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Pieksämäki
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Finland
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Rauma
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Finland
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Rovaniemi
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Finland
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Tampere
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France
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DAX
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France
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LA ROCHELLE cedex
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France
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Montpellier
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France
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Mougins
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France
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Narbonne
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France
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France
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Paris
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France
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Rennes
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France
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Saint Mandé
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Greece
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Athens
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India
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Maharashtra
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India
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Punjab
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India
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Chennai
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Mumbai
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Haifa
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Israel
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Jerusalem
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Israel
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Tel Hashomer
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Italy
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Catania
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Italy
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Lucca
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Italy
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Milano
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Italy
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Napoli
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Italy
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Perugia
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Ravenna
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Roma
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Cheras
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Bytom
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Kamieniec Zabkowicki
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Nysa
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Rawa Mazowiecka
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Tychy
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Warszawa
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Zabrze
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Romania
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Prahova
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Baia Mare
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Brasov
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Bucharest
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Timisoara
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South Africa
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Gauteng
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KwaZulu-Natal
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South Africa
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Umhlanga
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Spain
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Gijón
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Palma de Mallorca
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Spain
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Reus
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Switzerland
State/province [89] 0 0
Bern
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Zürich
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Changhua
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Kaohsiung City
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Taiwan
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Taipei
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Thailand
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Bangkok
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Turkey
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Ankara
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Turkey
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Antalya
Country [99] 0 0
Turkey
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Istanbul
Country [100] 0 0
Turkey
State/province [100] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Sullivan SD, Alfonso-Cristancho R, Conner C, Hamme... [More Details]
Journal Marre M, Shaw J, Brandle M, Bebakar WM, Kamaruddin... [More Details]
Journal Nauck M, Marre M. Adding liraglutide to oral antid... [More Details]
Journal McGill JB. Insights from the Liraglutide Clinical ... [More Details]
Journal Blonde L, Russell-Jones D. The safety and efficacy... [More Details]
Journal Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett... [More Details]
Journal Bode BW, Brett J, Falahati A, Pratley RE. Comparis... [More Details]
Journal Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, ... [More Details]
Journal Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Danie... [More Details]
Journal Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Ac... [More Details]
Journal Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft ... [More Details]
Journal Alves C, Batel-Marques F, Macedo AF. A meta-analys... [More Details]
Journal King AB, Montanya E, Pratley RE, Blonde L, Svendse... [More Details]
Journal Jensen TM, Saha K, Steinberg WM. Is there a link b... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00318422