Clinical trial NCT01029886: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide once weekly
Byetta
liraglutide
Victoza
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-12-10
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Patients Achieving HbA1c <7.0% at Week 26
timeFrame: Baseline, Week 26
measure: Change in Fasting Serum Glucose From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Body Weight From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Total Cholesterol From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Ratio of Fasting Triglycerides at Week 26 to Baseline
timeFrame: Baseline, Week 26
measure: Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research site
city: Rosario
country: Argentina
facility: Research Site
city: Box Hill
country: Australia
facility: Research Site
city: Geelong
country: Australia
facility: Research Site
city: Keswick
country: Australia
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research site
city: Edegem
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Charlottetown
country: Canada
facility: Research Site
city: Gatineau
country: Canada
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
city: Sherbrooke
country: Canada
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
city: Victoria
country: Canada
facility: Research Site
city: Windsor
country: Canada
facility: Research Site
city: Winnipeg
country: Canada
facility: Research Site
city: Brandys nad Labem
country: Czech Republic
facility: Research Site
city: Prague 2
country: Czech Republic
facility: Research Site
city: Prerov
country: Czech Republic
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Le Creuzot
country: France
facility: Research Site
city: Marseille Cedex 5
country: France
facility: Research Site
city: Marseille Cedex 9
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Bad Staffelstein
country: Germany
facility: Research Site
city: Beckum
country: Germany
facility: Research Site
city: Biberach
country: Germany
facility: Research Site
city: Datteln
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Meissen
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Riesa
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Cholargos
country: Greece
facility: Research Site
city: Patras
country: Greece
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Aligarh
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Coimbatore
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Indore
country: India
facility: Research Site
city: Karnal/Haryana
country: India
facility: Research Site
city: Karnataka
country: India
facility: Research site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Beer Sheva
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Raanana
country: Israel
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Treviglio
country: Italy
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Rzeszow
country: Poland
facility: Research site
city: Warszawa
country: Poland
facility: Research Site
city: Bucuresti
country: Romania
facility: Research site
city: Galati
country: Romania
facility: Research site
city: Iasi
country: Romania
facility: Research site
city: Oradea
country: Romania
facility: Research site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Malacky
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Halfway House
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Kempton Park
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Alcira
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Bilbao
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Teruel
country: Spain
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Jhonghe
country: Taiwan
facility: Research Site
city: Sindian
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Yung-Kang, Tainan
country: Taiwan
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.