Change in Glcosylated Hemoglobin (HbA1c)
| Group | Value (percentage) | Spread |
|---|---|---|
| Exenatide Arm | 8.59 | 0.07 |
| Biphasic Insulin Aspart Arm | 8.65 | 0.07 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataCroatia, Germany, Greece, Italy, Netherlands, Portugal, Romania, Russia, Slovenia, Spain, Taiwan, United Kingdom
1 trial · 1 completed · 1 with posted results
Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
NCT00082407Nov 2003 to Jul 2008
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
Experimental
Exenatide Arm
subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
Active comparator
Biphasic Insulin Aspart Arm
subcutaneous injection, twice daily; titration to target blood glucose level
Outcomes the sponsor listed as primary.
Change in Glcosylated Hemoglobin (HbA1c)
Time frame · baseline, week 52
Change in HbA1c from baseline to week 52
Percentage of Patients Achieving HbA1c <=7%
Time frame · 52 weeks
Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 52 (percentage = \[number of subjects with HbA1c \<=7% at week 52 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
Change in Body Weight
Time frame · baseline, week 52
Change in body weight from baseline to week 52.
Change in Fasting Serum Glucose
Time frame · baseline, week 52
Change in fasting serum glucose from baseline to week 52
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Time frame · baseline, week 52
Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52
Percentage of Patients With Hypoglycemic Events
Time frame · 52 weeks
Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study
Change in Rate of Hypoglycemic Events
Time frame · baseline, week 52
Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage) | Spread |
|---|---|---|
| Exenatide Arm | 8.59 | 0.07 |
| Biphasic Insulin Aspart Arm | 8.65 | 0.07 |
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Arm | 31.7 |
| Biphasic Insulin Aspart Arm | 24.1 |
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Arm | 85.51 | 0.99 |
| Biphasic Insulin Aspart Arm | 83.38 | 0.99 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Arm | 11.00 | 0.18 |
| Biphasic Insulin Aspart Arm | 11.30 | 0.18 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Arm | 9.57 | 2.34 |
| Biphasic Insulin Aspart Arm | 9.86 | 2.65 |
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Arm | 53.0 |
| Biphasic Insulin Aspart Arm | 51.6 |
| Group | Value (events per 30 days per patient) | Spread |
|---|---|---|
| Exenatide Arm | 0.22 | 0.07 |
| Biphasic Insulin Aspart Arm | 0.18 | 0.07 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Armsubcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks | – | 19 / ? | 179 / ? |
| Biphasic Insulin Aspart Armsubcutaneous injection, twice daily; titration to target blood glucose level | – | 11 / ? | 128 / ? |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
PubMed tag: none · 2012
Fineman et al. 2012Diabetes, obesity & metabolismcited by 117
PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356
PubMed tag: none · 2012
Pencek et al. 2012Postgraduate medicinecited by 45
PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891
Indexing hint: Randomized controlled trial · 2007
Nauck et al. 2007Diabetologiacited by 312
PMID 17160407DOI 10.1007/s00125-006-0510-2PUB-17160407
Who could join, as posted.
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