What NCT00935532 measured first
| Exenatide Once Weeklyn=214 | Insulin Glarginen=212 |
|---|---|
| -1.11(0.06) | -0.68(0.06) |
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.
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.
| Exenatide Once Weeklyn=214 | Insulin Glarginen=212 |
|---|---|
| -1.11(0.06) | -0.68(0.06) |
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide Once Weekly | Insulin Glargine |
|---|---|---|
| Any serious event | 2.8% | 2.4% |
| Injection site induration | 27% | 1.4% |
| Nasopharyngitis | 25.6% | 21.2% |
| Nausea | 12.6% | 2.8% |
| Constipation | 11.2% | 3.3% |
| Diarrhoea | 8.8% | 2.4% |
| Induration | 8.4% | 0% |
| Vomiting | 8.4% | 2.4% |
| Injection site pruritus | 6.5% | 0% |
| Abdominal discomfort | 5.1% | 0.9% |
| Decreased appetite | 5.1% | 0.5% |
| Exenatide Once Weeklyn=211 | Insulin Glarginen=210 |
|---|---|
| 42.2 | 21.0 |
| Exenatide Once Weeklyn=214 | Insulin Glarginen=212 |
|---|---|
| 20.6 | 4.2 |
| Exenatide Once Weeklyn=212 | Insulin Glarginen=211 |
|---|---|
| -46.09(2.40) | -40.82(2.39) |
| Exenatide Once Weeklyn=214 | Insulin Glarginen=212 |
|---|---|
| -1.67(0.17) | 0.34(0.17) |
| Exenatide Once Weeklyn=213 | Insulin Glarginen=212 |
|---|---|
| -14.21(1.67) | -6.32(1.67) |
| Exenatide Once Weeklyn=213 | Insulin Glarginen=212 |
|---|---|
| -0.99(0.52) | -0.71(0.51) |
| Exenatide Once Weeklyn=213 | Insulin Glarginen=212 |
|---|---|
| 1.00(1.02) | 1.00(1.02) |
| Measure | Exenatide Once Weeklyn=214 | Insulin Glarginen=212 |
|---|---|---|
| Systolic Blood Pressure | -4.5(14.04) | -2.6(14.29) |
| Diastolic Blood Pressure | -1.1(9.25) | -2.5(8.88) |
| Exenatide Once Weeklyn=215 | Insulin Glarginen=212 |
|---|---|
| 0.00(0.00) | 0.00(0.00) |
| Exenatide Once Weeklyn=215 | Insulin Glarginen=212 |
|---|---|
| 0.01(0.01) | 0.16(0.13) |
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.
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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.