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):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01029886
First received: December 8, 2009
Last updated: June 6, 2014
Last verified: June 2014

December 8, 2009
June 6, 2014
January 2010
January 2011   (final data collection date for primary outcome measure)
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.
To compare exenatide once weekly to once-daily liraglutide with respect to the difference in change in HbA1c from baseline to treatment endpoint [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01029886 on ClinicalTrials.gov Archive Site
  • 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.
  • To compare exenatide once weekly to once-daily liraglutide with respect to the proportion of subjects achieving HbA1c ≤7% and ≤6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide once weekly to once-daily liraglutide with respect to fasting serum glucose [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide once weekly to once-daily liraglutide with respect to change in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide once weekly to once-daily liraglutide with respect to serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides [TG], calculated low-density lipoprotein cholesterol [LDL-C]) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide once weekly to once-daily liraglutide with respect to safety and tolerability [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide once weekly to once-daily liraglutide with respect to hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide once weekly to once-daily liraglutide with respect to change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide once weekly
    subcutaneous injection, 2mg, once weekly
  • Drug: liraglutide
    subcutaneous injection, forced titration to 1.8mg, once daily
    Other Name: Victoza
  • Experimental: 1
    Intervention: Drug: exenatide once weekly
  • Active Comparator: 2
    Intervention: Drug: liraglutide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
912
April 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Taiwan,   Korea, Republic of,   Mexico,   Poland,   Romania,   Slovakia,   South Africa,   Spain
 
NCT01029886
H8O-MC-GWDE
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP