Phase 3 · Exenatide

NCT00917267 trial results

A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications

Change in HbA1c From Baseline to Week 26. (percentage of total hemoglobin), Baseline, Week 26. Exenatide Once Weekly: -1.43; Exenatide Twice Daily: -1.12.

Participants
691
Status
completed
Completed
2011-04
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00917267), updated at source Apr 9, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00917267 measured first

Change in HbA1c From Baseline to Week 26.percentage of total hemoglobin · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=307Exenatide Twice Dailyn=263
-1.43(0.07)-1.12(0.07)
Side effects by arm

Side effects in NCT00917267

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

EventExenatide Once WeeklyExenatide Twice Daily
Any serious event3.8%2.4%
Nausea9.4%21.6%
Vomiting7.9%11.5%
Injection site induration9.7%0.6%
Diarrhoea9.4%8%
Decreased appetite4.4%8.3%
Constipation5.9%7.1%
Dyslipidaemia6.2%6.8%
Injection site nodule5.3%0%
Injection site pruritus5.3%2.7%
Secondary outcomes

What else it measured

Percentage of Patients Achieving HbA1c Targets <=7% at Week 26percentage of patients · Baseline, Week 26 · number
Exenatide Once Weeklyn=332Exenatide Twice Dailyn=333
46.735.7
Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26percentage of patients · Baseline, Week 26 · number
Exenatide Once Weeklyn=338Exenatide Twice Dailyn=335
26.015.5
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26mg/dL · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=307Exenatide Twice Dailyn=274
-40.57(2.36)-23.90(2.45)
Change in Body Weight (BW) From Baseline to Week 26kg · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=309Exenatide Twice Dailyn=265
-1.63(0.16)-2.45(0.16)
Change in Total Cholesterol (TC) From Baseline to Week 26mg/dL · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=309Exenatide Twice Dailyn=277
-9.41(1.96)-8.10(2.04)
Change in High-Density Lipoprotein (HDL) From Baseline to Week 26mg/dL · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=309Exenatide Twice Dailyn=277
-0.11(0.41)-0.48(0.43)
Ratio of Triglycerides (TG) at Week 26 to Baselineratio · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=309Exenatide Twice Dailyn=277
0.97(0.02)0.97(0.03)
Change in Blood Pressure From Baseline to Week 26mmHg · Baseline, Week 26 · mean
MeasureExenatide Once Weeklyn=337Exenatide Twice Dailyn=335
Systolic Blood Pressure-5.33(15.99)-5.22(16.23)
Diastolic Blood Pressure-1.47(9.52)-2.24(9.56)
Assessment of Event Rate of Treatment-emergent Hypoglycemic Eventsevents per subject-year · Baseline to Week 26 · mean
MeasureExenatide Once Weekly With SU Use at Screeningn=264Exenatide Twice Daily With SU Use at Screeningn=267Exenatide Once Weekly Without SU Use at Screeningn=76Exenatide Twice Daily Without SU Use at Screeningn=71
Major Hypoglycemia0.00(0.000)0.01(0.007)0.00(0.000)0.00(0.000)
Minor Hypoglycemia0.24(0.069)0.59(0.180)0.03(0.027)0.11(0.113)
The trial

How NCT00917267 was run

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

  • 1
  • 2
Who could join the trial

Inclusion Criteria: * Have been diagnosed with type 2 diabetes. * Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive. * Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive. * Have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start). * Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start. Exclusion Criteria: * Have any contraindication for the OAD(s) that they use. * Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents. * Have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption. * Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start. * Have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start: * Insulin * Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin) * Pramlintide acetate * Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics. * Have had prior exposure to exenatide * Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * Are currently enrolled in any other clinical study.

Published papers

Papers from NCT00917267

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.