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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01029886
First received: December 8, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: exenatide once weekly
Drug: liraglutide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Change in HbA1c From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline to the treatment endpoint at Week 26.


Secondary Outcome Measures:
  • Percentage of Patients Achieving HbA1c <7.0% at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.

  • Change in Fasting Serum Glucose From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.

  • Change in Body Weight From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in body weight from baseline to the treatment endpoint at Week 26.

  • Change in Total Cholesterol From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in total cholesterol from baseline to the treatment endpoint at Week 26.

  • Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in HDL-C from baseline to the treatment endpoint at Week 26.

  • Ratio of Fasting Triglycerides at Week 26 to Baseline [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    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.

  • Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in SBP from baseline to the treatment endpoint at Week 26.

  • Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in DBP from baseline to the treatment endpoint at Week 26.

  • Assessment of Event Rate of Treatment-emergent Hypoglycemic Events [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 912
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: exenatide once weekly
subcutaneous injection, 2mg, once weekly
Active Comparator: 2 Drug: liraglutide
subcutaneous injection, forced titration to 1.8mg, once daily
Other Name: Victoza

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029886

  Show 110 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01029886     History of Changes
Other Study ID Numbers: H8O-MC-GWDE
Study First Received: December 8, 2009
Results First Received: February 14, 2012
Last Updated: January 14, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Therapeutic Goods Administration (TGA)
Austria: Agency for Health and Food Safety, Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization for Medicines
Hungary: National Institute of Pharmacy
India: Ministry of Health: Drug Control General of India (DCGI)
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Mexico: National Institute of Public Health, Health Secretariat
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española del Medicamento y Productos Sanitarios
Taiwan: Department of Health

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
exenatide once weekly
Byetta
liraglutide
 Victoza
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glucagon-Like Peptide 1
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013