Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

March 20, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

912

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
  • Australia
      • Box Hill, Australia
        • Research Site
      • Geelong, Australia
        • Research Site
      • Keswick, Australia
        • Research Site
  • Austria
      • Vienna, Austria
        • Research Site
  • Belgium
      • Bonheiden, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
  • Canada
      • Charlottetown, Canada
        • Research Site
      • Gatineau, Canada
        • Research Site
      • Ottawa, Canada
        • Research Site
      • Sherbrooke, Canada
        • Research Site
      • Vancouver, Canada
        • Research Site
      • Victoria, Canada
        • Research Site
      • Windsor, Canada
        • Research Site
      • Winnipeg, Canada
        • Research Site
  • Czech Republic
      • Brandys nad Labem, Czech Republic
        • Research Site
      • Prague 2, Czech Republic
        • Research Site
      • Prerov, Czech Republic
        • Research Site
  • France
      • Grenoble, France
        • Research Site
      • Le Creuzot, France
        • Research Site
      • Marseille, France
        • Research Site
      • Marseille Cedex 5, France
        • Research Site
      • Marseille Cedex 9, France
        • Research Site
      • Paris, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Reims Cedex, France
        • Research Site
      • Strasbourg, France
        • Research Site
  • Germany
      • Bad Staffelstein, Germany
        • Research Site
      • Beckum, Germany
        • Research Site
      • Biberach, Germany
        • Research Site
      • Datteln, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Meissen, Germany
        • Research Site
      • Muenster, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Riesa, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Cholargos, Greece
        • Research Site
      • Patras, Greece
        • Research Site
  • Hungary
      • Bekescsaba, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Mako, Hungary
        • Research Site
      • Mosonmagyarovar, Hungary
        • Research Site
      • Nagykanizsa, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
  • India
      • Aligarh, India
        • Research Site
      • Bangalore, India
        • Research Site
      • Chennai, India
        • Research Site
      • Coimbatore, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Indore, India
        • Research Site
      • Karnal/Haryana, India
        • Research Site
      • Karnataka, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Pune, India
        • Research Site
  • Israel
      • Beer Sheva, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Raanana, Israel
        • Research Site
  • Italy
      • Bari, Italy
        • Research Site
      • Cagliari, Italy
        • Research Site
      • Catanzaro, Italy
        • Research Site
      • Chieti, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Treviglio, Italy
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
      • Ulsan, Korea, Republic of
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Rzeszow, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Romania
      • Bucuresti, Romania
        • Research Site
      • Galati, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Oradea, Romania
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Malacky, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
  • South Africa
      • Halfway House, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Kempton Park, South Africa
        • Research Site
      • Parktown, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Spain
      • Alcira, Spain
        • Research Site
      • Alicante, Spain
        • Research Site
      • Bilbao, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Majadahonda, Spain
        • Research Site
      • Teruel, Spain
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Jhonghe, Taiwan
        • Research Site
      • Sindian, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Yung-Kang, Tainan, Taiwan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: liraglutide
subcutaneous injection, forced titration to 1.8mg, once daily
Other Names:
  • Victoza
EXPERIMENTAL: 1
Drug: exenatide once weekly
subcutaneous injection, 2mg, once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HbA1c from baseline to the treatment endpoint at Week 26.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Achieving HbA1c <7.0% at Week 26
Time Frame: Baseline, Week 26
Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.
Baseline, Week 26
Change in Fasting Serum Glucose From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in body weight from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in total cholesterol from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HDL-C from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time Frame: Baseline, Week 26
Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.
Baseline, Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in SBP from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in DBP from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Time Frame: Baseline to Week 26
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (ESTIMATE)

December 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWDE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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