parallel randomized trial
NCT00382239
A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo BID | sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: none | 40 | 40 | |
| A2 | Exenatide 2.5 µg injection twice daily Exenatide 2.5 ug BID | sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: none | 38 | 37 | |
| A3 | Exenatide 5 ug subcutaneous twice daily Exenatide 5 ug BID | sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: none | 37 | 37 | |
| A4 | Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug BID | sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: none | 38 | 37 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Exenatide 2.5 µg injection twice daily A2 | Exenatide 5 ug subcutaneous twice daily A3 | Exenatide 10 ug subcutaneous twice daily A4 |
|---|---|---|---|---|---|
| age | mean (years) | 60.5 | 62.2 | 60.7 | 57.8 |
| age | sd (years) | 10.2 | 7.8 | 9.8 | 10.4 |
| bmi | mean (kg/m2) | 25.8 | 24.2 | 25.0 | 26.1 |
| bmi | sd (kg/m2) | 4.6 | 3.3 | 3.4 | 5.3 |
| diabetes duration | mean (years) | 11.9 | 14.8 | 11.3 | 9.6 |
| diabetes duration | sd (years) | 6.0 | 10.9 | 6.4 | 6.0 |
| hba1c | mean (percent) | 8.1 | 8.0 | 7.9 | 7.9 |
| hba1c | sd (percent) | 0.7 | 0.8 | 0.8 | 0.9 |
| other background: su agi | n | 0 | 4 | 2 | 1 |
| other background: su agi | percent | 0.0 | 10.8 | 5.4 | 2.7 |
| other background: su alone | n | 4 | 3 | 2 | 3 |
| other background: su alone | percent | 10.0 | 8.1 | 5.4 | 8.1 |
| other background: su bg agi | n | 9 | 4 | 8 | 7 |
| other background: su bg agi | percent | 22.5 | 10.8 | 21.6 | 18.9 |
| other background: su bg meglitinide | n | 0 | 0 | 2 | 1 |
| other background: su bg meglitinide | percent | 0.0 | 0.0 | 5.4 | 2.7 |
| other background: su bg | n | 18 | 17 | 18 | 18 |
| other background: su bg | percent | 45.0 | 45.9 | 48.6 | 48.6 |
| other background: su tzd agi | n | 5 | 6 | 1 | 5 |
| other background: su tzd agi | percent | 12.5 | 16.2 | 2.7 | 13.5 |
| other background: su tzd | n | 4 | 3 | 4 | 2 |
| other background: su tzd | percent | 10.0 | 8.1 | 10.8 | 5.4 |
| other male | n | 30 | 26 | 25 | 23 |
| other male | percent | 75.0 | 70.3 | 67.6 | 62.2 |
| weight | mean (kg) | 71.1 | 64.9 | 65.6 | 70.3 |
| weight | sd (kg) | 14.0 | 11.6 | 9.8 | 15.9 |
Analyses this trial contributes to
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
48 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (4 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | 0.02 percent | 0.1 | not stated; full analysis; R0027621:Results | ||
| 12 | A2 | change | -0.9 percent | 0.1 | not stated; full analysis; R0027621:Results | ||
| 12 | A3 | change | -1.2 percent | 0.1 | not stated; full analysis; R0027621:Results | ||
| 12 | A4 | change | -1.4 percent | 0.1 | not stated; full analysis; R0027621:Results |
Body weight change in kilograms (diabetes) (4 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | -0.7 kg | 0.2 | not stated; full analysis; R0027621:Results | ||
| 12 | A2 | change | 0.08 kg | 0.2 | not stated; full analysis; R0027621:Results | ||
| 12 | A3 | change | -0.2 kg | 0.3 | not stated; full analysis; R0027621:Results | ||
| 12 | A4 | change | -1.3 kg | 0.3 | not stated; full analysis; R0027621:Results |
HbA1c below 7 percent (4 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | responders | 2 / 39 | not stated; other; R0027621:Results | |||
| 12 | A2 | responders | 16 / 32 | not stated; other; R0027621:Results | |||
| 12 | A3 | responders | 25 / 35 | not stated; other; R0027621:Results | |||
| 12 | A4 | responders | 27 / 34 | not stated; other; R0027621:Results |
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 40 | not stated; full analysis; R0027621:Table 3 | ||||
| A2 | events | 10 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A3 | events | 16 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A4 | events | 20 / 37 | not stated; full analysis; R0027621:Table 3 |
All cause mortality (4 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 40 | not stated; full analysis; R0027621:p7 | ||||
| A2 | events | 0 / 37 | not stated; full analysis; R0027621:p7 | ||||
| A3 | events | 0 / 37 | not stated; full analysis; R0027621:p7 | ||||
| A4 | events | 0 / 37 | not stated; full analysis; R0027621:p7 |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 40 | not stated; full analysis; R0027621:p7 | ||||
| A2 | events | 1 / 37 | not stated; full analysis; R0027621:p7 | ||||
| A3 | events | 0 / 37 | not stated; full analysis; R0027621:p7 | ||||
| A4 | events | 0 / 37 | not stated; full analysis; R0027621:p7 |
Discontinuation due to adverse events (4 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 40 | not stated; full analysis; R0027621:Table 1 | ||||
| A2 | events | 3 / 37 | not stated; full analysis; R0027621:Table 1 | ||||
| A3 | events | 4 / 37 | not stated; full analysis; R0027621:Table 1 | ||||
| A4 | events | 5 / 37 | not stated; full analysis; R0027621:Table 1 |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 40 | not stated; full analysis; R0027621:Table 3 | ||||
| A2 | events | 4 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A3 | events | 3 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A4 | events | 13 / 37 | not stated; full analysis; R0027621:Table 3 |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 40 | not stated; full analysis; R0027621:Table 3 | ||||
| A2 | events | 2 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A3 | events | 5 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A4 | events | 3 / 37 | not stated; full analysis; R0027621:Table 3 |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 40 | not stated; full analysis; R0027621:Table 3 | ||||
| A2 | events | 1 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A3 | events | 4 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A4 | events | 3 / 37 | not stated; full analysis; R0027621:Table 3 |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 40 | not stated; full analysis; R0027621:Table 3 | ||||
| A2 | events | 4 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A3 | events | 4 / 37 | not stated; full analysis; R0027621:Table 3 | ||||
| A4 | events | 3 / 37 | not stated; full analysis; R0027621:Table 3 |
Acute pancreatitis (4 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 40 | not stated; full analysis; R0027621:p7 | ||||
| A2 | events | 0 / 37 | not stated; full analysis; R0027621:p7 | ||||
| A3 | events | 0 / 37 | not stated; full analysis; R0027621:p7 | ||||
| A4 | events | 0 / 37 | not stated; full analysis; R0027621:p7 |