parallel randomized trial
NCT02960659
Therapeutic Targets in African-American Youth With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Standard care or no added treatment Metformin | metformin titrated over 3 weeks to 1000 mg twice daily; lifestyle: standard | 14 | 11 | |
| A2 | Liraglutide 1.8 mg subcutaneous once daily Metformin and liraglutide | metformin 1000 mg twice daily; lifestyle: standard | 11 | 10 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Standard care or no added treatment A1 | Liraglutide 1.8 mg subcutaneous once daily A2 |
|---|---|---|---|
| age | mean (years) | 15.6 | 15.0 |
| age | sd (years) | 2.1 | 2.1 |
| asian | n | 0 | 0 |
| black | n | 13 | 11 |
| bmi | mean (kg/m2) | 39.4 | 38.2 |
| bmi | sd (kg/m2) | 7.9 | 8.0 |
| diabetes duration | mean (years) | 1.5 | 1.0 |
| female | n | 7 | 7 |
| female | percent | 50 | 64 |
| hba1c | mean (percent) | 6.4 | 7.4 |
| hba1c | sd (percent) | 0.7 | 0.9 |
| other race american indian alaska native | n | 0 | 0 |
| other race multiple | n | 0 | 0 |
| other race native hawaiian pacific islander | n | 0 | 0 |
| sbp | mean (mmHg) | 131 | 128 |
| sbp | sd (mmHg) | 14 | 14 |
| weight | mean (kg) | 116.2 | 113.3 |
| weight | sd (kg) | 25.3 | 23.3 |
| white | n | 0 | 0 |
Analyses this trial contributes to
- HbA1c changeChildren and adolescents with type 2 diabetes; weeks 12 to 40 (target week 26); network meta-analysis
- HbA1c changeChildren and adolescents with type 2 diabetes; weeks 12 to 40 (target week 26); descriptive only
- Level 2 or 3 hypoglycemia (participants)Children and adolescents with type 2 diabetes; longest follow-up; descriptive only
- Level 2 or 3 hypoglycemia (participants)Children and adolescents with type 2 diabetes; longest follow-up; descriptive only
- Serious adverse eventsChildren and adolescents with type 2 diabetes; longest follow-up; descriptive only
- Serious adverse eventsChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- NauseaChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- NauseaChildren and adolescents with type 2 diabetes; longest follow-up; descriptive only
- VomitingChildren and adolescents with type 2 diabetes; longest follow-up; descriptive only
- VomitingChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- DiarrheaChildren and adolescents with type 2 diabetes; longest follow-up; descriptive only
- DiarrheaChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
Results
12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | final | 47.1 mmol/mol | 39.4 to 54.7 | not stated; per protocol; R0019860:Table 1 | ||
| 12 | A2 | final | 50.0 mmol/mol | 34.2 to 65.8 | not stated; per protocol; R0019860:Table 1 |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 13 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 11 | not stated; safety; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 13 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 11 | not stated; safety; registry:adverse_events |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 13 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 11 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 13 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 11 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 13 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 11 | not stated; safety; registry:adverse_events |