crossover randomized trial
NCT02713477
A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | lifestyle: not reported | 20 | 20 | |
| A2 | insulin glargine and lixisenatide (iGlarLixi) iGlarLixi 5 U/5 ug | lifestyle: not reported | 20 | 20 | |
| A3 | insulin glargine and lixisenatide (iGlarLixi) iGlarLixi 10 U/10 ug | lifestyle: not reported | 20 | 20 | |
| A4 | Insulin glargine Insulin glargine 5 U | lifestyle: not reported | 20 | 20 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | iGlarLixi 5 U/5 ug A2 | iGlarLixi 10 U/10 ug A3 | Insulin glargine A4 | Whole trial ALL |
|---|---|---|---|---|---|---|
| age: 65 or older | n | 5 | ||||
| age: 65 or older | percent | 25.0 | ||||
| age: less than 65 | n | 15 | ||||
| age: less than 65 | percent | 75.0 | ||||
| age | mean (years) | 59.0 | ||||
| age | sd (years) | 8.5 | ||||
| bmi | mean (kg/m2) | 23.77 | ||||
| bmi | sd (kg/m2) | 3.26 | ||||
| diabetes duration | mean (years) | 6.91 | ||||
| diabetes duration | sd (years) | 6.25 | ||||
| female | n | 3 | ||||
| female | percent | 15.0 | ||||
| hba1c | mean (percent) | 8.06 | ||||
| hba1c | sd (percent) | 0.69 | ||||
| weight | mean (kg) | 64.56 | ||||
| weight | sd (kg) | 12.51 |
Results
92 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 3 / 20 | while on treatment; safety; R0013418:Supplement Appendix S1 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Acute kidney injury (4 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
All cause mortality (4 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Hospitalization for heart failure (4 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Discontinuation due to adverse events (4 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 3 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Discontinuation due to gastrointestinal adverse events (4 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Gallbladder and biliary disease (4 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Acute pancreatitis (4 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Medullary thyroid carcinoma (4 lines; O32A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Thyroid cancer (any) (4 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Diabetic retinopathy complications (4 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Nonarteritic anterior ischemic optic neuropathy (4 lines; O34)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Suicidal ideation or behavior (4 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Death by suicide (4 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Supplement Table S5 |
Gastroparesis (4 lines; O37A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Intestinal obstruction or ileus (4 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Pancreatic cancer (4 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |
Any cancer (4 lines; O39)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A2 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A3 | events | 0 / 20 | while on treatment; safety; R0013418:Results | ||||
| A4 | events | 0 / 20 | while on treatment; safety; R0013418:Results |