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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
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Argentina
State/province [2] 0 0
Mendoza
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Argentina
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Rosario
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Austria
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Vienna
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Belgium
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Bonheiden
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Belgium
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Edegem
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Belgium
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Genk
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Belgium
State/province [8] 0 0
Leuven
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Belgium
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Liege
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Canada
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Charlottetown
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Canada
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Gatineau
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Canada
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Ottawa
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Canada
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Sherbrooke
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Canada
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Vancouver
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Canada
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Victoria
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Canada
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Windsor
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Canada
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Winnipeg
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Czech Republic
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Brandys nad Labem
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Czech Republic
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Prague 2
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Czech Republic
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Prerov
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France
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Grenoble
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France
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Le Creuzot
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France
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Marseille Cedex 5
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France
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Marseille Cedex 9
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France
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Marseille
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France
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Paris
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France
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Poitiers
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France
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Reims Cedex
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France
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Strasbourg
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Germany
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Bad Staffelstein
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Germany
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Beckum
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Germany
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Biberach
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Germany
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Datteln
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Germany
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Dresden
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Germany
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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
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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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Mako
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Nagykanizsa
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Szekesfehervar
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India
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Aligarh
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India
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India
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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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Karnal/Haryana
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India
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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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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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Bari
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Cagliari
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Catanzaro
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Chieti
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Napoli
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Roma
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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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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
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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
No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
Trial website
https://clinicaltrials.gov/study/NCT01029886
Trial related presentations / publications
Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01029886