Phase 3 · Exenatide

NCT00641056 trial results

Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

Change in HbA1c From Baseline to Week 26 (percentage of total hemoglobin), Baseline, Week 26. Exenatide Once Weekly: -1.47; Insulin Glargine: -1.31.

Participants
467
Status
completed
Completed
2009-11
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00641056), updated at source Jun 15, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00641056 measured first

Change in HbA1c From Baseline to Week 26percentage of total hemoglobin · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=205Insulin Glarginen=206
-1.47(0.05)-1.31(0.06)
Side effects by arm

Side effects in NCT00641056

Percent of participants affected. The most common events the registry lists.

EventExenatide Once WeeklyInsulin Glargine
Any serious event4.7%4.5%
Nasopharyngitis12.9%17.5%
Nausea12.9%1.3%
Headache9.9%7.2%
Diarrhoea8.6%3.6%
Injection site nodule5.2%0%
Secondary outcomes

What else it measured

Percentage of Patients Achieving HbA1c <=7.0% at Week 26percentage of patients · Baseline, Week 26 · number
Exenatide Once Weeklyn=209Insulin Glarginen=207
62.254.1
Percentage of Patients Achieving HbA1c <=6.5% at Week 26percentage of patients · Baseline, Week 26 · number
Exenatide Once Weeklyn=227Insulin Glarginen=218
43.228.4
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26mmol/L · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=192Insulin Glarginen=197
-2.13(0.16)-2.76(0.16)
Change in Body Weight (BW) From Baseline to Week 26kg · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=207Insulin Glarginen=209
-2.63(0.20)1.42(0.20)
Change in Total Cholesterol From Baseline to Week 26mmol/L · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=191Insulin Glarginen=198
-0.12(0.06)-0.04(0.06)
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26mmol/L · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=191Insulin Glarginen=198
-0.00(0.01)0.01(0.01)
Ratio of Triglycerides at Week 26 to Baselineratio · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=191Insulin Glarginen=198
0.96(0.03)0.89(0.03)
Change in Blood Pressure From Baseline to Week 26mmHg · Baseline, Week 26 · mean
MeasureExenatide Once Weeklyn=233Insulin Glarginen=222
Systolic Blood Pressure-3.03(16.57)-0.63(14.88)
Diastolic Blood Pressure-1.15(10.08)-0.72(8.73)
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodesrate per subject-year · Baseline to Week 26 · mean
MeasureExenatide Once Weekly With SUn=69Insulin Glargine With SUn=66Exenatide Once Weekly No SUn=164Insulin Glargine No SUn=157
Major Hypoglycemia0.00(0.000)0.03(0.030)0.01(0.013)0.01(0.013)
Minor Hypoglycemia1.14(0.184)2.66(0.284)0.10(0.037)0.63(0.091)
The trial

How NCT00641056 was run

The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

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Who could join the trial

Inclusion Criteria: * Has type 2 diabetes and at least 18 years of age at screening. * Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening. * Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening. * Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening). * Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR * Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening. Exclusion Criteria: * Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study. * Have clinical signs or symptoms of liver disease, acute or chronic hepatitis. * Have a history of renal transplantation or are currently receiving renal dialysis. * Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. * Have had greater than three episodes of major hypoglycemia within 6 months prior to screening. * Have any contraindication for the oral antidiabetic agent which they use. * Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents. * Are known to have active proliferative retinopathy. * 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 screening. * Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: * Insulin * Thiazolidinediones (e.g., Actos® \[pioglitazone\] or Avandia® \[rosiglitazone\]) * Alpha-glucosidase inhibitors (e.g., Glyset® \[miglitol\] or Precose® \[acarbose\]) * Meglitinides (e.g., Prandin® \[repaglinide\] or Starlix® \[nateglinide\]). * Byetta® (exenatide BID formulation) * Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \[sitagliptin\], Galvus® \[vildagliptin\]) * Symlin® (pramlintide acetate). * Have had an organ transplant. * Have donated blood within 30 days of screening. * Have previously completed or withdrawn from this study or any other study investigating exenatide once...

Published papers

Papers from NCT00641056

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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