Change in Glycosylated Hemoglobin (HbA1c)
| Group | Value (percentage) | Spread |
|---|---|---|
| Exenatide Arm | 8.13 | 0.07 |
| Insulin Glargine Arm | 8.19 | 0.07 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Australia, Belgium, Brazil, Finland, Germany, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Sweden
1 trial · 1 completed · 1 with posted results
Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
NCT00082381Jun 2003 to Jul 2008
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
Experimental
Exenatide Arm
exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
Active comparator
Insulin Glargine Arm
subcutaneous injection, once daily; forced titration to target blood glucose level
Outcomes the sponsor listed as primary.
Change in Glycosylated Hemoglobin (HbA1c)
Time frame · Baseline, week 26
Change in HbA1c from baseline to week 26
Percentage of Patients Achieving HbA1c <=7%
Time frame · 26 weeks
Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 26 (percentage = \[number of subjects with HbA1c \<=7% at week 26 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
Change in Body Weight
Time frame · Baseline, week 26
Change in body weight from baseline to week 26
Change in Fasting Serum Glucose
Time frame · Baseline, week 26
Change in fasting serum glucose from baseline to week 26
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Time frame · Baseline, week 26
Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26
Percentage of Patients With Hypoglycemic Events
Time frame · 26 weeks
Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study
Change in Rate of Hypoglycemic Events
Time frame · Baseline, week 26
Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26
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 | 8.13 | 0.07 |
| Insulin Glargine Arm | 8.19 | 0.07 |
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Arm | 46.43 |
| Insulin Glargine Arm | 48.03 |
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Arm | 88.42 | 1.16 |
| Insulin Glargine Arm | 89.25 | 1.20 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Arm | 10.27 | 0.21 |
| Insulin Glargine Arm | 10.46 | 0.21 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Arm | 9.47 | 0.169 |
| Insulin Glargine Arm | 9.50 | 0.173 |
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Arm | 55.32 |
| Insulin Glargine Arm | 59.93 |
| Group | Value (events per 30 days per patient) | Spread |
|---|---|---|
| Exenatide Arm | 0.09 | 0.04 |
| Insulin Glargine Arm | 0.11 | 0.04 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide ArmExenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks) | – | 8 / ? | 226 / ? |
| Insulin Glargine ArmInsulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level) | – | 10 / ? | 160 / ? |
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 · 2005
Heine et al. 2005Annals of internal medicinecited by 548
PMID 16230722DOI 10.7326/0003-4819-143-8-200510180-00006PUB-16230722
Who could join, as posted.
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