What NCT00960661 measured first
| Exenatide (BET)n=247 | Insulin Lispro (BBT)n=263 |
|---|---|
| -1.13(0.053) | -1.10(0.051) |
A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 (percent of hemoglobin), Baseline, 30 weeks. Exenatide (BET): -1.13; Insulin Lispro (BBT): -1.10.
As posted on ClinicalTrials.gov (NCT00960661), 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 (BET)n=247 | Insulin Lispro (BBT)n=263 |
|---|---|
| -1.13(0.053) | -1.10(0.051) |
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide (BET) | Insulin Lispro (BBT) |
|---|---|---|
| Any serious event | 7.3% | 8.3% |
| Nausea | 32.4% | 1.6% |
| Vomiting | 12.4% | 1% |
| Nasopharyngitis | 11.7% | 6.4% |
| Diarrhoea | 10.8% | 5.1% |
| Dyspepsia | 6% | 1% |
| Bronchitis | 5.7% | 1.9% |
| Influenza | 5.7% | 5.1% |
| Headache | 5.7% | 3.5% |
| Back Pain | 3.8% | 1.6% |
| Decreased appetite | 3.8% | 0% |
| Abdominal pain | 3.5% | 0.3% |
| Urinary tract infection | 3.5% | 2.2% |
| Dizziness | 3.2% | 1.3% |
| Pharyngitis | 2.9% | 2.2% |
| arthralgia | 1.3% | 2.9% |
| Gastroenteritis | 2.5% | 0.6% |
| Constipation | 2.2% | 0.6% |
| musculoskeletal pain | 1% | 2.2% |
| tooth infection | 0.6% | 2.2% |
| Gastritis | 1.9% | 1% |
| Abdominal pain upper | 1.9% | 0.6% |
| pain in extremity | 1.6% | 1.9% |
| upper respiratory tract infection | 1% | 1.9% |
| hypertension | 0.6% | 1.9% |
| toothache | 0.3% | 1.9% |
| Exenatide (BET)n=244 | Insulin Lispro (BBT)n=263 |
|---|---|
| 46.7 | 42.6 |
| Exenatide (BET)n=244 | Insulin Lispro (BBT)n=263 |
|---|---|
| 26.2 | 25.5 |
| Exenatide (BET)n=243 | Insulin Lispro (BBT)n=262 |
|---|---|
| -0.46(0.155) | 0.18(0.150) |
| Exenatide (BET)n=237 | Insulin Lispro (BBT)n=254 |
|---|---|
| -0.14(0.050) | -0.03(0.049) |
| Exenatide (BET)n=237 | Insulin Lispro (BBT)n=254 |
|---|---|
| -0.04(0.012) | 0.03(0.012) |
| Exenatide (BET)n=232 | Insulin Lispro (BBT)n=245 |
|---|---|
| -0.12(0.042) | -0.03(0.042) |
| Exenatide (BET)n=247 | Insulin Lispro (BBT)n=263 |
|---|---|
| -2.45(0.255) | 2.11(0.247) |
| Exenatide (BET)n=207 | Insulin Lispro (BBT)n=227 |
|---|---|
| -4.13(0.952) | 0.37(0.919) |
| Exenatide (BET)n=207 | Insulin Lispro (BBT)n=227 |
|---|---|
| -0.64(0.594) | -0.14(0.572) |
| Measure | Exenatide (BET)n=247 | Insulin Lispro (BBT)n=263 |
|---|---|---|
| Baseline | 61.5(30.94) | 61.1(35.24) |
| Week 30 | 56.9(29.35) | 51.5(31.44) |
| Exenatide (BET)n=315 | Insulin Lispro (BBT)n=312 |
|---|---|
| 0.0(0.23) | 0.1(0.39) |
| Exenatide (BET)n=315 | Insulin Lispro (BBT)n=312 |
|---|---|
| 2.1(5.08) | 5.0(12.83) |
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
Inclusion Criteria: * Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start. * Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start: * Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or * Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start. * Have an HbA1C \> 7.0% and ≤ 10.0%. * Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2. Exclusion Criteria: * Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label. * Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications). * Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week. * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start. * Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Have previously completed or been withdrawn from this study after enrollment.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.