Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by (Responsible Party):	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01029886

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Exenatide Liraglutide

U.S. FDA Resources

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

Primary Outcome Measures:

HbA1c [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in HbA1c from baseline to the treatment endpoint at 26 weeks. The MMRM model will have change in HbA1c as the dependent variable; treatment, baseline HbA1c, HbA1c stratum, country, oral antidiabetic agents (OAD) stratum, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.

Secondary Outcome Measures:

Patients Achieving HbA1c <7.0% [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
The proportion of patients achieving HbA1c <7.0% at treatment endpoint 26 weeks, using last observation carried forward (LOCF) for missing data.
Fasting Serum Glucose [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in fasting serum glucose from baseline to the treatment endpoint at 26 weeks. The MMRM model will have change in fasting serum glucose as the dependent variable; treatment, baseline fasting serum glucose, HbA1c stratum, country, oral antidiabetic agents (OAD) stratum, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.
Body Weight [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in body weight from baseline to the treatment endpoint at 26 weeks. The MMRM model will have change in body weight as the dependent variable; treatment, baseline body weight, HbA1c stratum, country, oral antidiabetic agents (OAD) stratum, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.
Serum Lipids (TC, HDL-C, Fasting TG, and Calculated LDL-C) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in serum lipids from baseline. Descriptive Statistics by Treatment Group.
Systolic Blood Pressure (SBP) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in SBP from baseline to the treatment endpoint at 26 weeks. The MMRM model will have change in SBP as the dependent variable; treatment, baseline SBP, HbA1c stratum, country, oral antidiabetic agents (OAD) stratum, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.
Diastolic Blood Pressure (DBP) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in DBP from baseline to the treatment endpoint at 26 weeks. The MMRM model will have change in DBP as the dependent variable; treatment, baseline DBP, HbA1c stratum, country, oral antidiabetic agents (OAD) stratum, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.
Major Hypoglycemic Episodes [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
Overall Major Hypoglycemic Episodes Incidence
Minor Hypoglycemic Episodes for Patients Using SU [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
Overall Minor Hypoglycemic Episodes Incidence for Patients Using SU
Minor Hypoglycemic Episodes for Patients Not Using SU [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
Overall Minor Hypoglycemic Episodes Incidence for Patients Not Using SU

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 between 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, Inc.

Eli Lilly and Company

Investigators

Study Director:

Chief Medical Officer, MD

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals, Inc.
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:	February 14, 2012
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 - French Health Products Safety Agency 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, Inc.:

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 23, 2012