parallel randomized trial
NCT02690883
Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy: a 24- Week Study
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Insulin lispro (prandial) Insulin lispro plus glargine | insulin glargine titrated to FPG 4.4 to 7.2 mmol/L; lifestyle: not reported | 46 | 38 | |
| A2 | Exenatide 10 ug subcutaneous twice daily Exenatide plus glargine | insulin glargine titrated to fasting glucose target; other glucose lowering drugs stopped; lifestyle: not reported | 46 | 43 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Insulin lispro (prandial) A1 | Exenatide 10 ug subcutaneous twice daily A2 |
|---|---|---|---|
| age | mean (years) | 56.2 | 55.9 |
| age | sd (years) | 8.0 | 8.9 |
| bmi | mean (kg/m2) | 23.5 | 26.1 |
| bmi | sd (kg/m2) | 3.1 | 3.4 |
| diabetes duration | mean (years) | 11.4 | 10.9 |
| diabetes duration | sd (years) | 7.0 | 6.2 |
| egfr | mean (mL/min/1.73 m2) | 69.2 | 71.5 |
| egfr | sd (mL/min/1.73 m2) | 24.6 | 22.5 |
| established cvd | n | 13 | 12 |
| established cvd | percent | 28.3 | 26.1 |
| hba1c | mean (percent) | 9.0 | 9.1 |
| hba1c | sd (percent) | 1.3 | 1.4 |
| other male | n | 29 | 35 |
| other male | percent | 63.0 | 76.1 |
| sbp | mean (mmHg) | 140.3 | 139.1 |
| sbp | sd (mmHg) | 14.6 | 16.7 |
| uacr | median (mg/g) | 1380.9 | 1146.2 |
| uacr | q1 (mg/g) | 601.8 | 709.4 |
| uacr | q3 (mg/g) | 2951.5 | 2488.2 |
Analyses this trial contributes to
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- 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 eventsChronic kidney disease with diabetes; longest follow-up; descriptive only
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsChronic kidney disease with diabetes; longest follow-up; descriptive only
- Discontinuation due to adverse eventsChronic kidney disease with diabetes; longest follow-up; descriptive only
- Discontinuation due to adverse eventsChronic kidney disease with diabetes; longest follow-up; descriptive only
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
14 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | 1.30 kg | 0.66 | not stated; full analysis; R0011086:Results | ||
| 24 | A1 vs A2 | md | 2.68 kg | not stated; full analysis; R0011086:Results | |||
| 24 | A2 | change | -1.38 kg | 0.63 | not stated; full analysis; R0011086:Results |
Level 2 or 3 hypoglycemia (participants) (3 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 46 | not stated; safety; R0011086:Results | ||||
| A1 | events | 20 / 46 | not stated; safety; R0011086:Results | ||||
| A2 | events | 10 / 46 | not stated; safety; R0011086:Results |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 46 | not stated; safety; R0011086:Results | ||||
| A2 | events | 1 / 46 | not stated; safety; R0011086:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 46 | not stated; safety; R0011086:Results | ||||
| A2 | events | 5 / 46 | not stated; safety; R0011086:Results |
Nausea (1 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 46 | not stated; safety; R0011086:Results |
Vomiting (1 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 46 | not stated; safety; R0011086:Results |
Diarrhea (1 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 46 | not stated; safety; R0011086:Results |
Constipation (1 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 46 | not stated; safety; R0011086:Results |