Primary outcomeLeast squares mean· Baseline, Week 26
Change in HbA1c From Baseline to Week 26
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.28 | 0.05 |
| Liraglutide Once Daily | -1.48 | 0.05 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSafety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
NCTNCT01029886 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWDE
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 912 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Open label (no masking)
- Countries
21 countries
Argentina, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Poland, Romania, Slovakia, South Africa, South Korea, Spain, Taiwan
- Start
- Jan 2010
- Primary completion
- Jan 2011
- Completion
- Apr 2011
- First posted
- 10 Dec 2009 (estimated)
- Last update posted
- 9 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012
- Ph 3
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
NCT01029886Jan 2010 to Apr 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatide once weeklyDrug
- liraglutideDrug
Arms2
Experimental
1
Active comparator
2
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in HbA1c from baseline to the treatment endpoint at Week 26.
Secondary outcomes(9)
Percentage of Patients Achieving HbA1c <7.0% at Week 26
Time frame · Baseline, Week 26
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline, Week 26
Percentage of Patients Achieving HbA1c <7.0% at Week 26
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 52.7 |
| Liraglutide Once Daily | 60.2 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Fasting Serum Glucose From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.76 | 0.11 |
| Liraglutide Once Daily | -2.12 | 0.12 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Body Weight From Baseline to Week 26
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.68 | 0.18 |
| Liraglutide Once Daily | -3.57 | 0.18 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -0.06 | 0.04 |
| Liraglutide Once Daily | -0.15 | 0.04 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.02 | 0.01 |
| Liraglutide Once Daily | 0.02 | 0.01 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
| Group | Value (ratio) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.97 | 0.02 |
| Liraglutide Once Daily | 0.89 | 0.02 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.48 | 0.56 |
| Liraglutide Once Daily | -3.45 | 0.57 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Once WeeklySubcutaneous injection, 2mg, once weekly | – | 13 / 461 | 160 / 461 |
| Liraglutide Once DailySubcutaneous injection, forced titration to 1.8mg, once daily | – | 7 / 450 | 212 / 450 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Randomized controlled trial · 2013
10 results
Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study.
Buse et al. 2013Lancet (London, England)cited by 405
PMID 23141817DOI 10.1016/s0140-6736(12)61267-7PUB-23141817
Full text at the publisher10 results
Indexing hint: Randomized controlled trial · 2013
16 results
Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.
Grimm et al. 2013Postgraduate medicinecited by 52
PMID 23748506DOI 10.3810/pgm.2013.05.2660PUB-23748506
Full text at the publisher16 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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