Phase 3 · Exenatide

NCT00935532 trial results

Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)

Change in HbA1c From Baseline to Endpoint (Week 26) (percentage of total hemoglobin), Baseline, Week 26. Exenatide Once Weekly: -1.11; Insulin Glargine: -0.68.

Participants
427
Status
completed
Completed
2011-07
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00935532), 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 NCT00935532 measured first

Change in HbA1c From Baseline to Endpoint (Week 26)percentage of total hemoglobin · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=214Insulin Glarginen=212
-1.11(0.06)-0.68(0.06)
Side effects by arm

Side effects in NCT00935532

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

EventExenatide Once WeeklyInsulin Glargine
Any serious event2.8%2.4%
Injection site induration27%1.4%
Nasopharyngitis25.6%21.2%
Nausea12.6%2.8%
Constipation11.2%3.3%
Diarrhoea8.8%2.4%
Induration8.4%0%
Vomiting8.4%2.4%
Injection site pruritus6.5%0%
Abdominal discomfort5.1%0.9%
Decreased appetite5.1%0.5%
Secondary outcomes

What else it measured

Percentage of Subjects Achieving HbA1c<=7%percentage of subjects · Baseline, Week 26 · number
Exenatide Once Weeklyn=211Insulin Glarginen=210
42.221.0
Percentage of Subjects Achieving HbA1c<=6.5%percentage of subjects · Baseline, Week 26 · number
Exenatide Once Weeklyn=214Insulin Glarginen=212
20.64.2
Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)mg/dL · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=212Insulin Glarginen=211
-46.09(2.40)-40.82(2.39)
Change in Body Weight From Baseline to Endpoint (Week 26)kg · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=214Insulin Glarginen=212
-1.67(0.17)0.34(0.17)
Change in Total Cholesterol From Baseline to Endpoint (Week 26)mg/dL · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=213Insulin Glarginen=212
-14.21(1.67)-6.32(1.67)
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)mg/dL · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=213Insulin Glarginen=212
-0.99(0.52)-0.71(0.51)
Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baselineratio · Baseline, Week 26 · least squares mean
Exenatide Once Weeklyn=213Insulin Glarginen=212
1.00(1.02)1.00(1.02)
Change in Blood Pressure From Baseline to Endpoint (Week 26)mmHg · Baseline, Week 26 · mean
MeasureExenatide Once Weeklyn=214Insulin Glarginen=212
Systolic Blood Pressure-4.5(14.04)-2.6(14.29)
Diastolic Blood Pressure-1.1(9.25)-2.5(8.88)
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Eventsevents per subject-year · Baseline to Week 26 · mean
Exenatide Once Weeklyn=215Insulin Glarginen=212
0.00(0.00)0.00(0.00)
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Eventsevents per subject-year · Baseline to Week 26 · mean
Exenatide Once Weeklyn=215Insulin Glarginen=212
0.01(0.01)0.16(0.13)
The trial

How NCT00935532 was run

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

  • exenatide once weekly
  • insulin glargine
Who could join the trial

Inclusion Criteria: * present with type 2 diabetes mellitus * HbA1c between 7.1% and 11.0% inclusive * body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive * treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start Exclusion Criteria: * Have received chronic (\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start. * Have been treated with drugs that promote weight loss within 90 days prior to study start. * Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start. * Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered). * Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs * Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication. * Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start. * Have donated blood within 30 days prior to study start.

Published papers

Papers from NCT00935532

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.