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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - liraglutide
Treatment: Drugs - rosiglitazone
Treatment: Drugs - glimepiride

Treatment: Drugs: liraglutide


Treatment: Drugs: rosiglitazone


Treatment: Drugs: glimepiride
Intervention code [1] 0 0
Treatment: Drugs
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
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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
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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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
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Finland
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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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NEVERS cedex
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Paris
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Rennes
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Saint Mandé
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Greece
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Athens
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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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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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Bytom
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Gniewkowo
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Kamieniec Zabkowicki
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Nysa
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Rawa Mazowiecka
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Szczecin
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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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South Africa
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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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Reus
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Switzerland
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Bern
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Switzerland
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Lausanne
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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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Ankara
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Antalya
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Turkey
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Istanbul
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Turkey
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Izmir

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00318422
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00318422