Skip to main content
OpenTrials
Completed

NCT Number: NCT01029886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide once weekly

Drug

subcutaneous injection, 2mg, once weekly

liraglutide

Drug

subcutaneous injection, forced titration to 1.8mg, once daily

Other names: Victoza

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2009
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.