What NCT00434954 measured first
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| -1.00(0.05) | -1.14(0.05) |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| 8.0 | 20.5 |
Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment
Change in Glycosylated Hemoglobin (HbA1c) (Percentage of glycosylated hemoglobin), Baseline and 26 weeks. Exenatide Twice Daily: -1.00; Premixed Insulin Aspart Twice Daily: -1.14.
As posted on ClinicalTrials.gov (NCT00434954), 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.
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| -1.00(0.05) | -1.14(0.05) |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| 8.0 | 20.5 |
Percent of participants affected, 26 weeks. The most common events the registry lists.
| Event | Exenatide Twice Daily | Premixed Insulin Aspart Twice Daily |
|---|---|---|
| Any serious event | 3.6% | 3.4% |
| Nausea | 18.6% | 3.4% |
| Nasopharyngitis | 15% | 18% |
| Diarrhea | 10.9% | 6.9% |
| Headache | 10.5% | 10.7% |
| Vomiting | 8.9% | 0.9% |
| Dyspepsia | 6.1% | 0.9% |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| 27.6 | 24.9 |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| 49.2 | 56.6 |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| 1.8 | 6.3 |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| 3.9 | 7.0 |
| Measure | Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|---|
| Pre-breakfast at baseline (week 0) | 8.933(1.7138) | 9.005(2.0432) |
| Pre-breakfast at endpoint (week 26) | 7.774(1.7730) | 7.293(1.3349) |
| 2 hrs post-breakfast at baseline (week 0) | 10.821(2.5306) | 10.902(2.8499) |
| 2 hrs post-breakfast at endpoint (week 26) | 8.014(2.0557) | 8.304(2.1212) |
| Pre-lunch at baseline (week 0) | 8.443(2.1814) | 8.357(2.3221) |
| Pre-lunch at endpoint (week 26) | 7.506(1.8800) | 6.656(1.7011) |
| 2 hrs post-lunch at baseline (week 0) | 9.698(2.2370) | 9.899(2.6433) |
| 2 hrs post-lunch at endpoint (week 26) | 8.513(5.8997) | 8.216(1.6108) |
| Pre-dinner at baseline (week 0) | 8.684(2.0059) | 8.759(2.2174) |
| Pre-dinner at endpoint (week 26) | 7.616(2.1727) | 7.194(1.5572) |
| 2 hrs post-dinner at baseline (week 0) | 10.241(2.2880) | 10.259(2.4868) |
| 2 hrs post-dinner at endpoint (week 26) | 7.727(1.8820) | 8.143(1.5614) |
| Measure | Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|---|
| Total cholesterol at baseline (week 0) | 5.147(1.0008) | 5.084(1.0079) |
| Total cholesterol at endpoint (week 26) | 4.971(0.9653) | 5.050(0.8933) |
| HDL cholesterol at baseline (week 0) | 1.234(0.3065) | 1.255(0.3324) |
| HDL cholesterol at endpoint (week 26) | 1.244(0.2805) | 1.319(0.3394) |
| LDL cholesterol (calculated) at baseline (week 0) | 2.845(0.8308) | 2.768(0.8103) |
| LDL cholesterol (calculated) at endpoint (week 26) | 2.738(0.8472) | 2.852(0.8134) |
| Triglycerides at baseline (week 0) | 2.391(1.5497) | 2.410(1.4398) |
| Triglycerides at endpoint (week 26) | 2.234(1.1886) | 2.006(1.2040) |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| -4.10(0.22) | 1.02(0.22) |
| Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|
| -1.39(0.07) | 0.32(0.07) |
| Measure | Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|---|
| DTSQ score at baseline (week 0) | 29.5(6.13) | 29.7(6.25) |
| DTSQ score at endpoint (week 26) | 30.6(6.05) | 29.3(6.59) |
| Measure | Exenatide Twice Dailyn=181 | Premixed Insulin Aspart Twice Dailyn=173 |
|---|---|---|
| Physical Component at baseline (week 0) | 35.5(13.99) | 36.3(14.45) |
| Physical Component at endpoint (week 26) | 39.1(14.30) | 37.7(14.28) |
| Mental Component at baseline (week 0) | 31.3(18.33) | 28.3(19.43) |
| Mental Component at endpoint (week 26) | 31.1(19.38) | 29.6(18.36) |
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
Inclusion Criteria: * Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start * Have an HbA1c between 6.5% and 10.0%, inclusive * Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive Exclusion Criteria: * Have type 1 diabetes or known latent autoimmune diabetes in adults * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start * Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics) * Have used any prescription drug to promote weight loss within 3 months prior to study start * Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry * Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.