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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01029886




Registration number
NCT01029886
Ethics application status
Date submitted
8/12/2009
Date registered
10/12/2009
Date last updated
9/04/2015

Titles & IDs
Public title
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
Scientific title
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications
Secondary ID [1] 0 0
H8O-MC-GWDE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 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 - exenatide once weekly
Treatment: Drugs - liraglutide

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: exenatide once weekly
subcutaneous injection, 2mg, once weekly

Treatment: Drugs: liraglutide
subcutaneous injection, forced titration to 1.8mg, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 26
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Percentage of Patients Achieving HbA1c <7.0% at Week 26
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [2] 0 0
Change in Fasting Serum Glucose From Baseline to Week 26
Timepoint [2] 0 0
Baseline, Week 26
Secondary outcome [3] 0 0
Change in Body Weight From Baseline to Week 26
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Change in Total Cholesterol From Baseline to Week 26
Timepoint [4] 0 0
Baseline, Week 26
Secondary outcome [5] 0 0
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Timepoint [5] 0 0
Baseline, Week 26
Secondary outcome [6] 0 0
Ratio of Fasting Triglycerides at Week 26 to Baseline
Timepoint [6] 0 0
Baseline, Week 26
Secondary outcome [7] 0 0
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Timepoint [8] 0 0
Baseline, Week 26
Secondary outcome [9] 0 0
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Timepoint [9] 0 0
Baseline to Week 26

Eligibility
Key inclusion criteria
* Diagnosed with type 2 diabetes
* Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive
* Have a body mass index (BMI) =45 kg/m^2
* Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:

* metformin
* SU
* metformin plus an SU
* metformin plus pioglitazone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents
* If taking metformin and have a contraindication to metformin use
* Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route
* Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of study start
* Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:

* Insulin
* Alpha-glucosidase inhibitors (e.g., Glyser® [miglitol] or Precose® [acarbose])
* Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide])
* Avandia® (rosiglitazone)
* Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin], Onglyza™ [saxagliptin])
* Symlin® (pramlintide acetate)
* Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start
* Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog
* Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have previously been screen-failed from this study for any reason
* If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
912
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Geelong
Recruitment hospital [3] 0 0
Research Site - Keswick
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Geelong
Recruitment postcode(s) [3] 0 0
- Keswick
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Mendoza
Country [3] 0 0
Argentina
State/province [3] 0 0
Rosario
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Bonheiden
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Belgium
State/province [7] 0 0
Genk
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liege
Country [10] 0 0
Canada
State/province [10] 0 0
Charlottetown
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Canada
State/province [11] 0 0
Gatineau
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Canada
State/province [12] 0 0
Ottawa
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Canada
State/province [13] 0 0
Sherbrooke
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Canada
State/province [14] 0 0
Vancouver
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Canada
State/province [15] 0 0
Victoria
Country [16] 0 0
Canada
State/province [16] 0 0
Windsor
Country [17] 0 0
Canada
State/province [17] 0 0
Winnipeg
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Brandys nad Labem
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Prague 2
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Prerov
Country [21] 0 0
France
State/province [21] 0 0
Grenoble
Country [22] 0 0
France
State/province [22] 0 0
Le Creuzot
Country [23] 0 0
France
State/province [23] 0 0
Marseille Cedex 5
Country [24] 0 0
France
State/province [24] 0 0
Marseille Cedex 9
Country [25] 0 0
France
State/province [25] 0 0
Marseille
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France
State/province [26] 0 0
Paris
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France
State/province [27] 0 0
Poitiers
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France
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Reims Cedex
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France
State/province [29] 0 0
Strasbourg
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Germany
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Bad Staffelstein
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Germany
State/province [31] 0 0
Beckum
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Germany
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Biberach
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Germany
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Datteln
Country [34] 0 0
Germany
State/province [34] 0 0
Dresden
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Germany
State/province [35] 0 0
Essen
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Germany
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Ludwigshafen
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Germany
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Mainz
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Germany
State/province [38] 0 0
Meissen
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Germany
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Muenster
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Germany
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Regensburg
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Germany
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Riesa
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Germany
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Stuttgart
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Greece
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Athens
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Greece
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Cholargos
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Greece
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Patras
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Mako
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Hungary
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Mosonmagyarovar
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Hungary
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Nagykanizsa
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Hungary
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Szekesfehervar
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India
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Aligarh
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India
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Bangalore
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India
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Chennai
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India
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Coimbatore
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India
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Hyderabad
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India
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Indore
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India
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Karnal/Haryana
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India
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Karnataka
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India
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Mumbai
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India
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Pune
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Raanana
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Italy
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Bari
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Italy
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Cagliari
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Italy
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Catanzaro
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Italy
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Chieti
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Napoli
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Italy
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Roma
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Italy
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Treviglio
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Bialystok
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Krakow
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Lodz
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Rzeszow
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Warszawa
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Romania
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Bucuresti
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Romania
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Galati
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Romania
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Iasi
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Romania
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Oradea
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Malacky
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Slovakia
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Martin
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South Africa
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Halfway House
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South Africa
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Johannesburg
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South Africa
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Kempton Park
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South Africa
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Parktown
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South Africa
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Pretoria
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Spain
State/province [97] 0 0
Alcira
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Spain
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Alicante
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Spain
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Bilbao
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Teruel
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Taiwan
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Changhua
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Taiwan
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Jhonghe
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Taiwan
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Sindian
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taichung
Country [107] 0 0
Taiwan
State/province [107] 0 0
Yung-Kang, Tainan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Chief Medical Officer, MD
Address 0 0
Eli Lilly and Company
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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01029886