What NCT00917267 measured first
| Exenatide Once Weeklyn=307 | Exenatide Twice Dailyn=263 |
|---|---|
| -1.43(0.07) | -1.12(0.07) |
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.
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.
| Exenatide Once Weeklyn=307 | Exenatide Twice Dailyn=263 |
|---|---|
| -1.43(0.07) | -1.12(0.07) |
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide Once Weekly | Exenatide Twice Daily |
|---|---|---|
| Any serious event | 3.8% | 2.4% |
| Nausea | 9.4% | 21.6% |
| Vomiting | 7.9% | 11.5% |
| Injection site induration | 9.7% | 0.6% |
| Diarrhoea | 9.4% | 8% |
| Decreased appetite | 4.4% | 8.3% |
| Constipation | 5.9% | 7.1% |
| Dyslipidaemia | 6.2% | 6.8% |
| Injection site nodule | 5.3% | 0% |
| Injection site pruritus | 5.3% | 2.7% |
| Exenatide Once Weeklyn=332 | Exenatide Twice Dailyn=333 |
|---|---|
| 46.7 | 35.7 |
| Exenatide Once Weeklyn=338 | Exenatide Twice Dailyn=335 |
|---|---|
| 26.0 | 15.5 |
| Exenatide Once Weeklyn=307 | Exenatide Twice Dailyn=274 |
|---|---|
| -40.57(2.36) | -23.90(2.45) |
| Exenatide Once Weeklyn=309 | Exenatide Twice Dailyn=265 |
|---|---|
| -1.63(0.16) | -2.45(0.16) |
| Exenatide Once Weeklyn=309 | Exenatide Twice Dailyn=277 |
|---|---|
| -9.41(1.96) | -8.10(2.04) |
| Exenatide Once Weeklyn=309 | Exenatide Twice Dailyn=277 |
|---|---|
| -0.11(0.41) | -0.48(0.43) |
| Exenatide Once Weeklyn=309 | Exenatide Twice Dailyn=277 |
|---|---|
| 0.97(0.02) | 0.97(0.03) |
| Measure | Exenatide Once Weeklyn=337 | Exenatide 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) |
| Measure | Exenatide Once Weekly With SU Use at Screeningn=264 | Exenatide Twice Daily With SU Use at Screeningn=267 | Exenatide Once Weekly Without SU Use at Screeningn=76 | Exenatide Twice Daily Without SU Use at Screeningn=71 |
|---|---|---|---|---|
| Major Hypoglycemia | 0.00(0.000) | 0.01(0.007) | 0.00(0.000) | 0.00(0.000) |
| Minor Hypoglycemia | 0.24(0.069) | 0.59(0.180) | 0.03(0.027) | 0.11(0.113) |
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.
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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.