Phase 3 · Exenatide

NCT00082381 trial results

Effect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

Participants
551
Status
completed
Completed
2008-07
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00082381), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00082381 measured first

Change in Glycosylated Hemoglobin (HbA1c)percentage · Baseline, week 26 · least squares mean
MeasureExenatide Armn=275Insulin Glargine Armn=260
Baseline HbA1c8.13(0.07)8.19(0.07)
Change in HbA1c at week 26-1.00(0.06)-1.05(0.06)
Side effects by arm

Side effects in NCT00082381

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

EventExenatide ArmInsulin Glargine Arm
Hypoglycemia55.3%59.9%
Nausea57.1%8.6%
Vomiting17.4%3.7%
Nasopharyngitis7.8%9%
Headache8.9%8.6%
Diarrhea8.5%3%
Back pain6%3%
Influenza2.5%5.6%
Upper respiratory tract infection5.3%4.9%
Dizziness5.3%2.2%
Secondary outcomes

What else it measured

Percentage of Patients Achieving HbA1c <=7%percentage of participants · 26 weeks · number
Exenatide Armn=282Insulin Glargine Armn=267
46.4348.03
Change in Body Weightkg · Baseline, week 26 · least squares mean
MeasureExenatide Armn=231Insulin Glargine Armn=244
Baseline body weight88.42(1.16)89.25(1.20)
Change in body weight at week 26-2.32(0.21)1.75(0.21)
Change in Fasting Serum Glucosemmol/L · Baseline, week 26 · least squares mean
MeasureExenatide Armn=258Insulin Glargine Armn=245
Baseline fasting serum glucose10.27(0.21)10.46(0.21)
Change in fasting serum glucose at week 26-1.22(0.19)-2.86(0.19)
Change in 7-point Self-monitored Blood Glucose (SMBG) Profilemmol/L · Baseline, week 26 · least squares mean
MeasureExenatide Armn=282Insulin Glargine Armn=267
Pre-breakfast: Baseline SMBG9.47(0.169)9.50(0.173)
Pre-breakfast: Change in SMBG at week 26-1.25(0.130)-2.56(0.132)
2hr post breatfast: Baseline SMBG12.51(0.220)12.36(0.226)
2hr post breakfast: Change in SMBG at week 26-3.77(0.171)-2.86(0.174)
Pre-lunch: Baseline SMBG9.61(0.218)9.47(0.224)
Pre-lunch: Change in SMBG at week 26-1.50(0.156)-1.93(0.158)
2hr post lunch: Baseline SMBG11.15(0.222)10.96(0.226)
2hr post lunch: Change in SMBG at week 26-1.68(0.173)-1.69(0.176)
Pre-dinner: Baseline SMBG9.46(0.211)9.35(0.216)
Pre-dinner: Change in SMBG at week 26-1.15(0.156)-1.72(0.159)
2hr post dinner: Baseline SMBG11.17(0.206)11.49(0.211)
2hr post dinner: Change in SMBG at week 26-3.06(0.172)-1.65(0.175)
Percentage of Patients With Hypoglycemic Eventspercentage of participants · 26 weeks · number
Exenatide Armn=282Insulin Glargine Armn=267
55.3259.93
Change in Rate of Hypoglycemic Eventsevents per 30 days per patient · Baseline, week 26 · least squares mean
MeasureExenatide Armn=282Insulin Glargine Armn=267
Baseline event rate0.09(0.04)0.11(0.04)
Change in event rate at week 260.23(0.06)0.29(0.06)
The trial

How NCT00082381 was run

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

  • Exenatide Arm: exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
  • Insulin Glargine Arm: subcutaneous injection, once daily; forced titration to target blood glucose level
Who could join the trial

Inclusion Criteria: * Patients have been treated with a stable dose of one of the following for at least 3 months prior to screening: 1. 1500 to 2550 mg/day immediate-release metformin (or 1500 to 2000 mg/day extended-release metformin) and at least an optimally effective dose of a sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components. * HbA1c between 7.0% and 10.0%, inclusive. * History of stable body weight (not varying by \>10% for at least three months prior to screening). * Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) Exclusion Criteria: * Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * Patients are employed by Lilly or Amylin. * Patients have participated in this study previously or any other study using AC2993 or GLP-1 analogs. * Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. * Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening. * Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer. * Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. * Patients have a known allergy or hypersensitivity to insulin glargine, AC2993, or excipients contained in these agents. * Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label, in the opinion of the investigator. * Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine \>=1.5 mg/dL for males and \>=1.3 mg/dL for females. * Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamicpyruvic transaminase greater than three times the upper limit of the reference range. * Patients have known hemoglobinopathy or chronic anemia. * Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. * Patients have used any prescription drug to promote weight loss within 3 months prior to screening. * Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. * Patients fail to satisfy the investigator of suitability to participate for any other...

Published papers

Papers from NCT00082381

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

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