The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Group | 47 |
| Placebo Group | 12 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name MEXELIN
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics. The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen. There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.
Active comparator
1
Participants will receive exenatide as part of their diabetes treatment
Placebo comparator
2
Participants will receive placebo rather than exenatide as part of their diabetes treatment
Outcomes the sponsor listed as primary.
The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Time frame · After 24 weeks of randomized treatment
The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Time frame · After 24 weeks of randomized treatment
efficacy criteria, 50% of per protocol participants reached A1c target of \<6.5%
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Group | 47 |
| Placebo Group | 12 |
| Group | Value (percentage of participants) | Spread |
|---|---|---|
| Exenatide Group | 50 | 0.27 |
| Placebo Group | 12 | – |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Run-In GroupAll participants took exenatide twice daily in addition to their Metformin dose. | – | 0 / 38 | 21 / 38 |
| Exenatide Randomization GroupAfter run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels | – | 0 / 17 | 15 / 17 |
| Placebo Randomization PeriodAfter run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels | – | 0 / 17 | 10 / 17 |
| Exenatide Open-Label (Previous Exenatide)Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level | – | 0 / 14 | 11 / 14 |
| Exenatide Open-Label (Previous Placebo)Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level | – | 0 / 17 | 12 / 17 |
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